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

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

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

Study Overview

• Status: Completed
• Conditions: Critically Ill; Ventilation and Oxygenation; Obese; Positioning
• Intervention / Treatment: Other: Reverse Trendelenburg position; Other: Semi-recumbent position

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21548
    • Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• body mass index ≥ 30
• Mechanically ventilated

Exclusion Criteria:

• Trauma
• Shock
• Acute respiratory distress syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reverse Trendelenburg position group; Obese critically ill patients who are positioned in reverse Trendelenburg position	Other: Reverse Trendelenburg position; The Reverse Trendelenburg position is a position in which patients' hip and knee are not flexed but the head and chest are elevated at 30° than the abdomen and legs.
Active Comparator: Semi-recumbent position group; Obese critically ill patients who are positioned in semi-recumbent position which is the routine ICU position	Other: Semi-recumbent position; The semi-recumbent position is an upright positioning of the head and torso at an angle of 45° while legs are lying on the bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory dynamic compliance	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.	30 minute form positioning time
Respiratory minute volume	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.	30 minute form positioning time
Partial pressure carbon dioxide	Partial pressure carbon dioxide (PaCO2) in mm Hg is assessed from arterial blood gases sample.	30 minute form positioning time
Partial pressure oxygen	Partial pressure oxygen (PaO2) in mm Hg is assessed from arterial blood gases sample.	30 minute form positioning time
Hypoxemic index	Hypoxemic index is the ratio of partial pressure oxygen to fraction inspiratory oxygen (PaO2/FiO2).	30 minute form positioning time

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): March 12, 2020

Study Registration Dates

• First Submitted: April 18, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: ventilation; oxygenation; obese patients; Reverse Trendelenburg position; semi-recumbent position
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 1212020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Researchers are waiting to get approval from research committee to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No