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Completed

NCT Number: NCT04376047

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

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

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Key information

Conditions

Ventilation and Oxygenation Body Weight Critical Illness Critically Ill Disease Attributes Nutrition Disorders Nutritional and Metabolic Diseases Obese; Positioning Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University

Alexandria, 21548, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • body mass index ≥ 30
  • Mechanically ventilated

Exclusion criteria

  • Trauma
  • Shock
  • Acute respiratory distress syndrome

Treatment and study plan

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.

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.

Primary outcomes

  1. Respiratory dynamic compliance

    Time frame: 30 minute form positioning time

    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.

  2. Respiratory minute volume

    Time frame: 30 minute form positioning time

    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.

  3. Partial pressure carbon dioxide

    Time frame: 30 minute form positioning time

    Partial pressure carbon dioxide (PaCO2) in mm Hg is assessed from arterial blood gases sample.

  4. Partial pressure oxygen

    Time frame: 30 minute form positioning time

    Partial pressure oxygen (PaO2) in mm Hg is assessed from arterial blood gases sample.

  5. Hypoxemic index

    Time frame: 30 minute form positioning time

    Hypoxemic index is the ratio of partial pressure oxygen to fraction inspiratory oxygen (PaO2/FiO2).

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 6, 2020
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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