Respiratory and Hemodynamics Parameters Response to Positive End-Expiratory Pressure

Not Applicable

Completed

• Conditions: Obesity Associated Disorder
• Interventions: Device: respiratory parameters on mechanical ventilator (PEEP)

• Registration Number: NCT05508997
• Lead Sponsor: Heidy F. Ahmed

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)).

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2022-06-17
• Study Completion: 2022-06-30
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-13
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive End Expiatory Pressure + Reverse Trendelenburg Position	respiratory parameters on mechanical ventilator (PEEP)	Group A received the procedures of the physiotherapy part by applying proper positioning for better oxygenation and ventilation (Reverse Trendelenburg Position), which is the patient laid supine with the head up 30 degrees higher than the feet \& received the recruitment maneuver (RM) by Positive End Expiratory Pressure (PEEP) titration
Reverse Trendelenburg Position	respiratory parameters on mechanical ventilator (PEEP)	Group B received only the procedures of the physiotherapy part at the 3rd phase of operation by applying proper positioning for better oxygenation and ventilation (Reverse Trendelenburg Position), in which the patient laid supine with the head at 15-30 degrees higher than the feet to unload the weight of intra-abdominal contents from the diaphragm, this position: 1. Increase pulmonary compliance, functional residual capacity (FRC), and oxygenation. 2. Allows easier ventilation. 3. This position called safe apnea time allows time to secure the airway before desaturation for a 20-minute positioning time.

Primary Outcome Measures

Name	Time	Method
Respiratory parameters	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 Outcome Measures

Name	Time	Method
Hemodynamics parameters	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).

Trial Locations

Locations (1)

Al Kasr Al Aini Teaching Hospital; 🇪🇬 Giza, Egypt