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NCT Number: NCT03024658

Effect of Positive End Expiratory Pressure at the Time of Induction in Morbidly Obese Patients

Background: Positive end expiratory pressure (PEEP) at the time of induction increases oxygenation by preventing lung atelectasis. However, PEEP may not prove beneficial in all cases. Factors affecting the action of PEEP have not been elucidated well and remain controversial. Pulmonary vasculature has direct bearing on the action of PEEP as has been proven in previous studies. Thus this study was planned to evaluate the action of PEEP on the basis of pulmonary artery systolic pressure (PASP) which is non invasive and easily measured by trans-thoracic echocardiography.

Methodology: This Randomized prospective study comprised of 70 morbidly obese patients, ASA grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic bariatric surgery. Ten patients had to be excluded. Thus a total of 60 patients participated in the study. Thirty patients received no PEEP at the time of induction while other 30 patients were given a PEEP of 10cm of H2O. Serial ABG samples were taken pre operatively, at the time of intubation, 5 min after intubation and 10 min after intubation. Patients were then divided into four groups on the basis of PASP value of ≤ 30 mm Hg with and without PEEP or > 30 mm Hg

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This prospective study was conducted in the Department Of Anaesthesiology& Critical Care, Sri Aurobindo Institute of Medical Sciences & P.G. Institute and Mohak Hospitals, Indore, over a period of one year. Seventy morbidly obese patients, ASA grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic bariatric surgery were selected and a written informed consent was obtained. All the recruited patients underwent 2D-trans-thoracic echocardiography and PASP was recorded. Echocardiography was performed by same cardiologist as this measurement is operator dependent. Patients who denied consent, those undergoing Emergency and/or open surgery and those requiring more than 2 attempts for intubation were excluded.

Arterial line was inserted pre operatively and ABG sample was taken and hemodynamic parameter recording done while the patient was breathing room air. Both groups were pre-oxygenated for 3 minutes with 100% Oxygen. Standard procedure was used for induction of anesthesia in all the patients. No premedication was given. All the patients were induced with i.v. Glycopyrolate (0.005-0.01 mg/kg), i.v. Fentanyl (2µg/kg) and i.v. Propofol. Once the patient became unresponsive to verbal commands, Succinylcholine was then administered in a dose of 1- 1.5 mg/ kg. Mechanical ventilation was started with 100% oxygen. A PEEP of 10 cm H2O was applied using four hand technique in Study group while the control group received no PEEP. After one minute endotracheal intubation was done. PEEP was continued in study group after intubation.

Arterial blood gas (ABG) analysis and hemodynamic parameters were recorded at following stages:

  • Just after inflation of cuff of endotracheal tube
  • 5 minutes post intubation
  • 10 minutes post intubation

Patients were then again divided into four groups on the basis of PASP:

Group 1: Patients with PASP ≤ 30 mmHg receiving no PEEP (n= 11) Group 2: PASP ≤ 30 mm Hg receiving PEEP of 10 cm H2O (n= 11) Group 3: PASP > 30 mm Hg receiving no PEEP (n= 19) Group 4: PASP > 30 mm Hg receiving PEEP of 10 cm H2O (n=19)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients recruited were

  • Anesthesia society of Anesthesiologist (ASA) physical status l, II or III,
  • Aged 20-65 years
  • BMI > 40kg/m2
  • scheduled for elective laparoscopic bariatric surgery

Exclusion criteria

  • Patients who denied consent
  • Did not fulfill the inclusion criteria,
  • patients undergoing Emergency and/or open surgery
  • Patients requiring more than 2 attempts for intubation

Treatment and study plan

positive end expiratory pressure (PEEP)

Other

Positive end expiratory pressure was applied using anesthesia machine at the time of induction in the patients undergoing laparoscopic bariatric surgery

Primary outcomes

  1. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Arterial oxygenation (PaO2) in mm Hg recorded preoperatively and taken as baseline value

    Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

  2. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia

    Time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded from ABG preoperatively and taken as baseline value

    Arterial carbon di oxide (PaCO2) values in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

  3. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia

    Time frame: Pulse Rate (beats/ min) was recorded from ABG preoperatively and taken as baseline value

    Pulse Rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

  4. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia

    Time frame: Systolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value

    Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

  5. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia

    Time frame: Diastolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value

    Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater

  6. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Arterial oxygenation (PaO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube

    Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube

  7. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube

    Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube

  8. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Pulse rate (beats/ min) was recorded just after the placement and cuff inflation of endotracheal tube

    Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube

  9. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Systolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube

    Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube

  10. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Diastolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube

    Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube

  11. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Arterial oxygenation (PaO2) in mm Hg was recorded five minutes post intubation

    Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation

  12. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded five minutes post intubation

    Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation

  13. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Pulse rate (beats/ min) was recorded five minutes post intubation

    Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation

  14. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Systolic BP in mm Hg was recorded five minutes post intubation

    Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation

  15. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Diastolic BP in mm Hg was recorded five minutes post intubation

    Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation

  16. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Arterial oxygenation (PaO2) in mm Hg was recorded ten minutes post intubation

    Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

  17. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded ten minutes post intubation

    Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

  18. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: pulse Rate (beats/ min) was recorded ten minutes post intubation

    Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

  19. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Systolic BP in mm Hg was recorded ten minutes post intubation

    Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

  20. effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction

    Time frame: Diastolic BP in mm Hg was recorded ten minutes post intubation

    Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation

Secondary outcomes

  1. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value

    Preoperative arterial oxygenation was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  2. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value

    Preoperative arterial carbon di oxide was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  3. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value

    Preoperative pulse rate was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  4. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value

    Systolic blood pressure was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  5. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value

    Diastolic blood pressure was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  6. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube

    Arterial oxygenation recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  7. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube

    Arterial carbon di oxide (mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  8. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube

    Pulse rate (beats/ min) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameters was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  9. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube

    Systolic pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  10. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube

    Diastolic blood pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  11. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded five minutes post intubation

    Arterial oxygenation recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  12. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded five minutes post intubation

    Arterial carbon di oxide (mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  13. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded five minutes post intubation

    Pulse rate (beats/ min) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  14. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded five minutes post intubation

    Systolic pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  15. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded five minutes post intubation

    Diastolic blood pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  16. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation

    Arterial oxygenation (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  17. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation

    Arterial carbon di oxide (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  18. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation

    Pulse rate (beats/ min) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  19. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation

    Systolic blood pressure (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

  20. Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters

    Time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation

    Diastolic blood pressure(mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP

Sponsors and collaborators

Lead sponsor

Sri Aurobindo Institute of Medical Sciences

Other

Registry information

Official study title

Single Minute of Positive End Expiratory Pressure at the Time of Induction: Effect on Arterial Blood Gases and Hemodynamics in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 19, 2017
Registry last updated
Jan 19, 2017

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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