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NCT Number: NCT03505632

High Versus Low Positive End Expiratory Pressure With Alveolar Recruitment Maneuver in Laparoscopic Bariatric Surgeries

For the patients undergoing laparoscopic bariatric surgery, application of low (PEEP) with frequent alveolar recruitment maneuver could be beneficial and superior to conventional ventilation with a high (PEEP) in improving lung compliance, better oxygenation and less dead space .This hypothesis could be achieved by minimizing the expected lung atelectasis during anesthesia for this particular kind of laparoscopic surgery without any haemodynamics alterations.This trial was designed to study the effects of alveolar recruitment strategy with low PEEP versus conventional mechanical ventilation with higher PEEP on the patients undergoing laparoscopic bariatric surgeries. The primary end point of the study will be the achievement of the highest dynamic lung compliance (Cdyn). Improvement of intraoperative oxygenation (Pao2/Fio2) and achievement of a lower dead space ratio (vd/vt), with stable intraoperative haemodynamics will be considered as secondary outcome

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura faculty of medicine

Al Mansurah, Dakahlia Governorate, Egypt

About this study

The use of a alveolar recruitment maneuver(RM) effectively increases end expiratory lung volume and reopens lung atelectasis during anesthesia and reproduces better oxygenation for surgical obese patients .Alveolar recruitment maneuver with PEEP could decreases atelectasis and improved oxygenation in obese surgical patients .This concept indicate that the maintenance of low PEEP after multiple alveolar recruitment maneuver during anesthesia may improve its benefits without complications. Patients will randomly divided by computerized randomization sequence method into two groups (30 patients in each study group):

Both groups receive volume controlled ventilation, tidal volume was 6-8 ml/kg for predicted body weight. The PBW calculated according to a formula: 50 + 0.91 × {height (cm)-152.4} for men and 45.5 + 0.91 × {height (cm) - 152.4} for women. The respiratory rate was adjusted to keep the EtCO2= 35-40 mmHg. The inspiratory to expiratory ratio (I:E ratio) was 1:2 and the FiO2 was 0.40.

Low PEEP+RM group: Patients receive PEEP of 5cmH2O. Recruitment maneuver ( RM) will be done by increasing the PEEP in stepwise manner. First PEEP was increased to 10 cmH2O (3 breaths),then to 15 cm H2O (3 breaths).Finally, PEEP was raised to 20 cmH2O (10 breaths).Then decreased for 15cmH2O for (3 breaths),10cmH2O for(3 breaths), and finally returned back to original PEEP 5 cmH2O.The total procedure took 2 min. Recruitment will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40cmH2O.

High PEEP group: Patients receive throughout ventilation 15 cm H2O PEEP with maintaining the peak airway pressure below 40 cm H2O.

Monitoring :after intubation(T1), post-insufflation(T2), after disinflation (T3) and before extubation(T4) for the fillowoing.1--Minute volume ,respiratory rate and tidal volume 2-Arterial blood gas( PaO2, PaCO2,pH).3-Hemodynamics : heart rate and invasive arterial blood pressure.4-Calculated dynamic Lung compliance by equation: T V/peak airway pressure- PEEP .5-calculated driving pressure by equation: Pplat-PEEP.6-Calculated dead space ratio (VD/VT) by equation :PaCO2-ETCO2)/ PaCO2.

Rescue strategies:

A) Intraoperative hypoxemia (SpO2≤92%): In both groups ,rescue primarily will be performed by an increase in FiO2 by 0.1 till reaching oxygen (100% ) .If failed and hypoxia persist a recruitment maneuver will be carried out with stepwise incremental PEEP irrespective of the group allocation.

The time of the event of hypoxia and its management will be recorded.

B) Intraoperative hypotension (systolic blood pressure <90 mmHg):

  • Abort any recruitment maneuver in low PEEP+ RM group.
  • Gradual decrease PEEP by 5 cmH2O in stepwise manner in higher PEEP group.
  • Give 500 ml bolus colloid and correct fluid status with blood transfusion if indicated.
  • Noradrenalin infusion as last resort

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status II and III.
  • Patients included in the study having body mass index ≥35kg/m2.
  • Both genders.
  • Age ≥ 20 years old.

Exclusion criteria

  • Major cardiovascular diseases (heart failure and ejection fraction below 40%).
  • Sever obstructive pulmonary diseases (FEV1 < 50 and FVC < 50)
  • Hepatic and renal impairment.
  • Younger than 20 years old.

Treatment and study plan

Recruitment with low PEEP

Device

Volume controlled ventilation with TV 6-8 ml/PBW . RR adjusted to keep the EtCO2 35-40 mmHg. I/E ratio1:2 and FiO2 0.40.Patients will receive PEEP of 5cmH2O. RM will be done by increasing the PEEP in stepwise manner. First PEEP increase to 10 cmH2O (3 breaths),then to 15 cm H2O (3 breaths) and finally PEEP raise to 20 cmH2O (10 breaths).Then PEEP decrease by 5 cmH2O increments every (3 breaths) until back to PEEP 5 cmH2O. RM will take 2 minutes. RM will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40 cmH2O. Monitoring of the following parameters :Dynamic lung compliance ,Horowitz index ,dead space and driving pressure .

Other names: Low PEEP + RM

High PEEP without RM

Device

Volume controlled ventilation will carried out with tidal volume 6-8 ml/kg for predicted body weight. The PBW calculated according to the formula : 50 + 0.91 × {height (cm)-152.4} for men and 45.5 + 0.91 × {height (cm) - 152.4} for women. The respiratory rate adjusted to keep the EtCO2= 35-40 mmHg. The inspiratory to expiratory ratio (I:E ratio) 1:2 and FiO2 0.40.Patients will receive high PEEP of 15cmH2O from the start and continue all through the procedure . Monitoring of dynamic lung compliance,Horowitz index,dead space and driving pressure will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40cmH2O.

Other names: High PEEP

Primary outcomes

  1. Dynamic lung compliance

    Time frame: During intra-operative mechanical ventilation

    To achieve nearly 20% increase in dynamic lung compliance (Cdyn) during anesthesia for obese patients undergoing bariatric surgery.

Secondary outcomes

  1. Horowitz ratio

    Time frame: During mechanical ventilation

    Improvement of intraoperative oxygenation with Horowitz ratio (Pao2/Fio2) more than 350.

  2. Alveolar dead space ratio

    Time frame: During mechanical ventilation

    Achievement of the least alveolar dead space ratio (vd/vt).

  3. Systolic blood pressure

    Time frame: During mechanical ventilation

    Maintain systolic blood pressure above 100 mmHg.

  4. Diastolic blood pressure

    Time frame: During mechanical ventilation

    Maintain diastolic blood pressure above 50 mmHg.

  5. Mean blood pressure

    Time frame: During mechanical ventilation

    Maintain mean blood pressure above 65 mmHg.

  6. Heart rate

    Time frame: During mechanical ventilation

    Maintain heart rate within the range of 60-90 (bpm ).

  7. Analgesia

    Time frame: postoperative time for 24 hours

    postoperative visual analogue score less than 4.

  8. Atelectasis

    Time frame: postoperative time for 24 hours

    Chest X-ray for evidences of atelectasis

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Low Positive End Expiratory Pressure With Alveolar Recruitment Maneveurs Versus High Positive End Expiratory Pressure as Lung Protective Strategy in Laparoscopic Bariatric Surgeries

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2018
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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