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

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376047
• Other study ID #: 1212020
• Status: Completed
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: March 12, 2020

Study information

• Verified date: May 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• body mass index = 30

• Mechanically ventilated

Exclusion Criteria:

• Trauma

• Shock

• Acute respiratory distress syndrome

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Obese; Positioning
• Ventilation and Oxygenation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Partial pressure carbon dioxide	Partial pressure carbon dioxide (PaCO2) in mm Hg is assessed from arterial blood gases sample.	30 minute form positioning time
Primary	Partial pressure oxygen	Partial pressure oxygen (PaO2) in mm Hg is assessed from arterial blood gases sample.	30 minute form positioning time
Primary	Hypoxemic index	Hypoxemic index is the ratio of partial pressure oxygen to fraction inspiratory oxygen (PaO2/FiO2).	30 minute form positioning time