Skip to main content
Clinical Trials/NCT04376047
NCT04376047CompletedNot Applicable

Effect of Reverse Trendelenburg Position Versus Semi-recumbent Position on Ventilation and Oxygenation Parameters in Obese Critically Ill Patients: Randomized Controlled Trial

Alexandria University2 sites in 1 country110 target enrollmentStarted: January 13, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
110
Locations
2
Primary Endpoint
Respiratory dynamic compliance

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Care Provider)

Masking Description

Computer generated randomization (www.randomizer.org) was used to randomly assign patients to one of both groups. Information of allocation was available to the principal researcher only. Patients were assigned a sequential number that was placed in an opaque, sealed envelope by the researcher. When the patients were scheduled to be positioning, the envelope was opened by the researcher who then performed the positioning. The nurses could not be blinded to the allocation because of the nature of the intervention. However, the outcome assessment of the patients was blinded.

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • body mass index ≥ 30
  • Mechanically ventilated

Exclusion Criteria

  • Acute respiratory distress syndrome

Outcomes

Primary Outcomes

Respiratory dynamic compliance

Time Frame: 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

Time Frame: 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

Time Frame: 30 minute form positioning time

Partial pressure carbon dioxide (PaCO2) in mm Hg is assessed from arterial blood gases sample.

Partial pressure oxygen

Time Frame: 30 minute form positioning time

Partial pressure oxygen (PaO2) in mm Hg is assessed from arterial blood gases sample.

Hypoxemic index

Time Frame: 30 minute form positioning time

Hypoxemic index is the ratio of partial pressure oxygen to fraction inspiratory oxygen (PaO2/FiO2).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials