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NCT Number: NCT05508997

Respiratory and Hemodynamics Parameters Response to Positive End-Expiratory Pressure

In this study, the sixty mechanically ventilated class I obese patients were divided into two equal groups A and B. group A received RTP position + PEEP protocol, while group B underwent RTP position protocol only. The results showed that the group A protocol has positive effects on the improvement of respiratory mechanics by significant increase the arterial oxygen partial pressure (PaO2) in mmHg to fractional inspired oxygen (FiO2), (PaO2/FiO2 ratio), partial pressure of carbon dioxide (PaCO2), and static compliance (Cstat) parameters. Moreover, a significant decrease in hemodynamics of BP& MAP was measured. While the results of the group B protocol demonstrated a non-significant increase in the PaO2/FiO2 ratio, PaCO2, and Cstat. Besides, non-significant decreases in hemodynamics of blood pressure (BP) & mean arterial blood pressure (MAP) were recorded.

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Key information

Conditions

Obesity Associated Disorder

Age range

40 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Kasr Al Aini Teaching Hospital

Giza, 12556, Egypt

About this study

Objective To investigate the effect of the positive end-expiratory pressure (PEEP) titration maneuver with Reverse Trendelenburg Position (RTP) on the respiratory and hemodynamic parameters of mechanically ventilated obese patients.

Design Randomized, control trial. Participants Thirty mechanically ventilated obese patients were randomized equally as a group A to receive Reverse Trendelenburg Position (RTP) + Positive End Expiratory Pressure (PEEP) titration, and group (B): receive Reverse Trendelenburg Position (RTP).

Intervention After post-operative bariatric surgeries, the sixty mechanically ventilated obese patients immediately receive a PEEP and RTP once before the weaning through the ventilator of the operation to evaluate the response of arterial blood gases before admission to the intensive care unit ICU room.

Outcomes The primary outcomes included the respiratory parameters (PaO2/FiO2 ratio, PaCO2, Cstat), and the secondary outcomes included the hemodynamics parameters (systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects included in this study had the following criteria:
  • Mechanically ventilated obese patients in operation room undergoing upper abdominal surgeries (bariatric) and under general anesthesia.
  • Obese patients with BMI (30-34.9).
  • Age 40-50 years old.
  • Both sexes.
  • Non-smoker.
  • No history of disease affecting the heart & lungs.

Exclusion criteria

  • Subjects with any of the following were excluded from the study:
  • Severe head injury.
  • Increase intracranial pressure and who are potentially liable to develop pathologically raised intracranial pressure.
  • Acute pulmonary edema.
  • Barotrauma/volutrauma.
  • Un-drained Pneumothorax/Hemothorax.
  • Flail chest.
  • Low blood pressure (systolic less than 80 mmHg).
  • Oxygen saturation is less than 90%.

Treatment and study plan

respiratory parameters on mechanical ventilator (PEEP)

Device

The 3rd & 4th phases of operation in the group (A) and (B): Each patient received one single session inside the Operation Room (OR) as one shot of the treatment procedure. Arterial Blood Gases (ABGs) were obtained to measure:

  • Oxygenation by PaO2/FiO2 ratio with constant FiO2 = 100% (oxygen) through the procedure time as a primary outcome.
  • Secondary outcome.
  • Ventilation by PaCO2 value from ABGs.
  • Static compliance (Cstat) was measured as the amount of recruitment of alveoli in the lung.
  • Blood pressure (systolic/diastolic) one of the hemodynamics measurements was measured pre/post the procedure in the two groups.

Primary outcomes

  1. Respiratory parameters

    Time frame: Immediately after the procedure is done in the operating room appears on the patient's monitor & patient arterial blood gases.

    The primary outcomes included the respiratory parameters partial oxygen pressure, partial carbon dioxide pressure, static compliance fractional oxygen pressure ratio

Secondary outcomes

  1. Hemodynamics parameters

    Time frame: Immediately after the procedure is done in the operating room appears on the patient's monitor.

    The secondary outcomes included the hemodynamics parameters (SBP in mmHg, DBP in mmHg, and MAP in mmHg).

Sponsors and collaborators

Lead sponsor

Heidy F. Ahmed

Other

Registry information

Official study title

Response of Respiratory and Hemodynamic Parameters to Positive End-Expiratory Pressure Titration for Mechanically Ventilated Obese Patients: A Randomized Clinical Trial

Acronym: Respiratory

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2022
Registry last updated
Feb 15, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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