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

Primary Purpose

Ventilation and Oxygenation, Obese; Positioning, Critically Ill

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Reverse Trendelenburg position
Semi-recumbent position
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ventilation and Oxygenation focused on measuring Reverse Trendelenburg position, semi-recumbent position, ventilation, oxygenation, obese patients

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • body mass index ≥ 30
  • Mechanically ventilated

Exclusion Criteria:

  • Trauma
  • Shock
  • Acute respiratory distress syndrome

Sites / Locations

  • Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reverse Trendelenburg position group

Semi-recumbent position group

Arm Description

Obese critically ill patients who are positioned in reverse Trendelenburg position

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

Outcomes

Primary Outcome Measures

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.
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.
Partial pressure carbon dioxide
Partial pressure carbon dioxide (PaCO2) in mm Hg is assessed from arterial blood gases sample.
Partial pressure oxygen
Partial pressure oxygen (PaO2) in mm Hg is assessed from arterial blood gases sample.
Hypoxemic index
Hypoxemic index is the ratio of partial pressure oxygen to fraction inspiratory oxygen (PaO2/FiO2).

Secondary Outcome Measures

Full Information

First Posted
April 18, 2020
Last Updated
May 2, 2020
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04376047
Brief Title
Reverse Trendelenburg Position Versus Semi-recumbent Position in Obese Critically Ill Patients
Official Title
Effect of Reverse Trendelenburg Position Versus Semi-recumbent Position on Ventilation and Oxygenation Parameters in Obese Critically Ill Patients: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilation and Oxygenation, Obese; Positioning, Critically Ill
Keywords
Reverse Trendelenburg position, semi-recumbent position, ventilation, oxygenation, obese patients

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two-group pre-test and repeated post-test study
Masking
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.
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reverse Trendelenburg position group
Arm Type
Experimental
Arm Description
Obese critically ill patients who are positioned in reverse Trendelenburg position
Arm Title
Semi-recumbent position group
Arm Type
Active Comparator
Arm Description
Obese critically ill patients who are positioned in semi-recumbent position which is the routine ICU position
Intervention Type
Other
Intervention Name(s)
Reverse Trendelenburg position
Intervention Description
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
Intervention Name(s)
Semi-recumbent position
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory dynamic compliance
Description
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.
Time Frame
30 minute form positioning time
Title
Respiratory minute volume
Description
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.
Time Frame
30 minute form positioning time
Title
Partial pressure carbon dioxide
Description
Partial pressure carbon dioxide (PaCO2) in mm Hg is assessed from arterial blood gases sample.
Time Frame
30 minute form positioning time
Title
Partial pressure oxygen
Description
Partial pressure oxygen (PaO2) in mm Hg is assessed from arterial blood gases sample.
Time Frame
30 minute form positioning time
Title
Hypoxemic index
Description
Hypoxemic index is the ratio of partial pressure oxygen to fraction inspiratory oxygen (PaO2/FiO2).
Time Frame
30 minute form positioning time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: body mass index ≥ 30 Mechanically ventilated Exclusion Criteria: Trauma Shock Acute respiratory distress syndrome
Facility Information:
Facility Name
Alexandria University
City
Alexandria
ZIP/Postal Code
21548
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Researchers are waiting to get approval from research committee to make individual participant data (IPD) available to other researchers

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

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