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

NCT ID: NCT04376047

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2020-03-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventilation and Oxygenation Obese; Positioning Critically Ill

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two-group pre-test and repeated post-test study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reverse Trendelenburg position group

Obese critically ill patients who are positioned in reverse Trendelenburg position

Group Type EXPERIMENTAL

Reverse Trendelenburg position

Intervention Type OTHER

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 group

Obese critically ill patients who are positioned in semi-recumbent position which is the routine ICU position

Group Type ACTIVE_COMPARATOR

Semi-recumbent position

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* body mass index ≥ 30
* Mechanically ventilated

Exclusion Criteria

* Trauma
* Shock
* Acute respiratory distress syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexandria University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alexandria University

Alexandria, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1212020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.