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

NCT04376047 | Completed DMC

• 1 other identifier: 1212020
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

Ventilation and Oxygenation; Obese; Positioning; Critically Ill

Keywords

Reverse Trendelenburg position; semi-recumbent position; ventilation; oxygenation; obese patients

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Reverse Trendelenburg position group

EXPERIMENTAL

Obese critically ill patients who are positioned in reverse Trendelenburg position

Other: Reverse Trendelenburg position

Semi-recumbent position group

ACTIVE COMPARATOR

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

Other: Semi-recumbent position

Interventions

Reverse Trendelenburg position 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.

Reverse Trendelenburg position group

Semi-recumbent position 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.

Semi-recumbent position group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index ≥ 30
• Mechanically ventilated

You may not qualify if:

• Trauma
• Shock
• Acute respiratory distress syndrome

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, 21548, Egypt

Location

MeSH Terms

Conditions

Respiratory Aspiration; Obesity; Critical Illness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-group pre-test and repeated post-test study

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: May 6, 2020
• Study Start: January 13, 2020
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

EG (1)