Clinical Trials Directory

Trials / Completed

CompletedNCT05508997

Respiratory and Hemodynamics Parameters Response to Positive End-Expiratory Pressure

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Heidy F. Ahmed · Academic / Other
Sex
All
Age
40 Years – 50 Years
Healthy volunteers
Accepted

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)).

Conditions

Interventions

TypeNameDescription
DEVICErespiratory parameters on mechanical ventilator (PEEP)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: 1. Oxygenation by PaO2/FiO2 ratio with constant FiO2 = 100% (oxygen) through the procedure time as a primary outcome. 2. 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.

Timeline

Start date
2021-12-01
Primary completion
2022-06-17
Completion
2022-06-30
First posted
2022-08-19
Last updated
2023-02-15

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05508997. Inclusion in this directory is not an endorsement.