Clinical trial NCT05508997: Respiratory and Hemodynamics Parameters Response to Positive End-Expiratory Pressure
Official title: Response of Respiratory and Hemodynamic Parameters to Positive End-Expiratory Pressure Titration for Mechanically Ventilated Obese Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Associated Disorder
Keywords: Positive end-expiratory pressure titration
Mechanical ventilator
respiratory and hemodynamics parameters
Obese patients
Reverse Trendelenburg Position.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group A receive Reverse Trendelenburg Position (RTP) + Positive End Expiratory Pressure (PEEP) titration, and group (B): receive Reverse Trendelenburg Position (RTP).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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)).

Eligibility criteria: Inclusion Criteria:

* Subjects included in this study had the following criteria:

  1. Mechanically ventilated obese patients in operation room undergoing upper abdominal surgeries (bariatric) and under general anesthesia.
  2. Obese patients with BMI (30-34.9).
  3. Age 40-50 years old.
  4. Both sexes.
  5. Non-smoker.
  6. No history of disease affecting the heart \& lungs.

Exclusion Criteria:

* Subjects with any of the following were excluded from the study:

  1. Severe head injury.
  2. Increase intracranial pressure and who are potentially liable to develop pathologically raised intracranial pressure.
  3. Acute pulmonary edema.
  4. Barotrauma/volutrauma.
  5. Un-drained Pneumothorax/Hemothorax.
  6. Flail chest.
  7. Low blood pressure (systolic less than 80 mmHg).
  8. Oxygen saturation is less than 90%.

Primary outcomes:
measure: Respiratory parameters
timeFrame: Immediately after the procedure is done in the operating room appears on the patient's monitor & patient arterial blood gases.
Secondary outcomes:
measure: Hemodynamics parameters
timeFrame: Immediately after the procedure is done in the operating room appears on the patient's monitor.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Al Kasr Al Aini Teaching Hospital
Study officials:
affiliation: Kasr al aini
name: Heidy F. Ahmed, Master
role: PRINCIPAL_INVESTIGATOR
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