Reverse Trendelenburg Position Versus Semi-recumbent Position in Obese Critically Ill Patients

Not Applicable

Completed

• Conditions: Ventilation and Oxygenation; Critically Ill; Obese; Positioning
• Interventions: Other: Reverse Trendelenburg position; Other: Semi-recumbent position

• Registration Number: NCT04376047
• Lead Sponsor: Alexandria University

Brief Summary

The aim of this study is to assess the effect of reverse Trendelenburg position versus semi-recumbent position on ventilation and oxygenation parameters of obese critically ill patients

Detailed Description

Obese critically ill patients' position significantly impacts on their ventilation and oxygenation status. It is also associated with mechanical ventilation success or failure and may be a main determinant of the obese patients' outcome. Reverse Trendelenburg position is recommended for obese patients but in critical illness with mechanical ventilation little is known about its effect on respiratory therapeutic targets. This trial was conducted in four general intensive care unit of Alexandria Main University hospital in Alexandria, Egypt. One hundred and ten adult mechanically ventilated patients with body mass index ≥ 30 were randomly assigned by a computer program to either reverse Trendelenburg position group (n=55) which is the intervention group or semi-recumbent position group (n=55) which is the routine unit position. Patients were positioned in the study positions 4 times per day. Patients were maintained in the study positions for 2 hours each time. Baseline ventilation and oxygenation parameters were assessed immediately before positioning then it was reassessed every 10 minutes after positioning for 30 minutes.

Study Timeline

• Study Start: 2020-01-13
• Primary Completion: 2020-03-12
• Study Completion: 2020-03-12
• Study First Submitted: 2020-04-18
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-02
• Last Update Submitted: 2020-05-02
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• body mass index ≥ 30
• Mechanically ventilated

Exclusion Criteria

• Trauma
• Shock
• Acute respiratory distress syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reverse Trendelenburg position group	Reverse Trendelenburg position	Obese critically ill patients who are positioned in reverse Trendelenburg position
Semi-recumbent position group	Semi-recumbent position	Obese critically ill patients who are positioned in semi-recumbent position which is the routine ICU position

Primary Outcome Measures

Name	Time	Method
Respiratory dynamic compliance	30 minute form positioning time	Respiratory dynamic compliance (Cdyn) in ml/cm H2O is the change in lung volume per unit change in pressure in the presence of flow. It is calculated through the equation of tidal volume/ (peak inspiratory pressure - positive end expiatory pressure). All the previous equation variables are assessed from the patient's mechanical ventilator data.
Respiratory minute volume	30 minute form positioning time	Respiratory minute volume (VE) in mL/min is the total volume of air that is expired over one minute. It is calculated directly by the mechanical ventilator and presented on patient's mechanical ventilator data.
Partial pressure carbon dioxide	30 minute form positioning time	Partial pressure carbon dioxide (PaCO2) in mm Hg is assessed from arterial blood gases sample.
Partial pressure oxygen	30 minute form positioning time	Partial pressure oxygen (PaO2) in mm Hg is assessed from arterial blood gases sample.
Hypoxemic index	30 minute form positioning time	Hypoxemic index is the ratio of partial pressure oxygen to fraction inspiratory oxygen (PaO2/FiO2).

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt