Prone Positioning in COVID-19 Patients

January 31, 2022 updated by: Kazim Rollas, Tepecik Training and Research Hospital

The Effect of Prone Positioning on Oxygenation and Respiratory Mechanics in Patients With COVID-19 Pneumonia

Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3).

The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6).

Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).

Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the recruitability position of the lung.in COVID-ARDS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3).

The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6).

Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the oxygenation, respiratory mechanics and recruitability position of the lung in COVID-ARDS.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with laboratory-confirmed COVID-19 admitted to the ICU
  • The patients receive invasive mechanical ventilation and meet the criteria for ARDS (Berlin definition) (8), with under continuous infusion of sedatives,

Exclusion Criteria:

  • Pregnancy
  • Pneumothorax and or chest tube
  • Chronic obstructive lung disease
  • interstitial lung disease
  • intraabdominal hypertension
  • increase in intracranial blood pressure
  • Haemodynamic unstability requiring vasopressors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Prone Positioning
Patients will be ventilated in volume-controlled mode with Vt at 6 ml/kg of predicted body weight. Prone positioning will be performed over periods of 16 hours when PaO2/FiO2 was persistently lower than 150 mm Hg. Flow, volume, and airway pressure will bw measured by ventilators. Measurements of oxygenation and respiratory mechanics were performed at 5 and 15 cmH20 PEEP levels and will be repeated every season as before first period of prone positioning, before supine positioning, and again before second period of prone positioning. Total PEEP and plateau pressure will be measured by a short end-expiratory and an end-inspiratory occlusion respectively. Complete airway closure will be assessed by performing a low-flow (4 L/min) inflation( PV tool) (9). The potential for lung recruitment will be assessed by means of the R/I ratio (10).
Other: Oxygenation
Oxygenation will be calculated as PaO2/ FiO2 ratio.Static compliance will be calculated as tidal volume divided driving pressure.The potential for lung recruitment will be assessed by means of the R/I ratio (10).
Other Names:
  • static compliance, Recruitability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation
Time Frame: intubation + 48 hours
PaO2/FiO2
intubation + 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static compliance
Time Frame: intubation + 48 hours
Tidal volume divided driving pressure
intubation + 48 hours
Recruitability
Time Frame: intubation + 48 hours
recruitment to inflation ratio
intubation + 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tepecik Training and Research Hospital

Investigators

  • Study Chair: Işıl Köse Güldoğan, İzmi̇r Tepeci̇k Eği̇ti̇m Ve Arştırma Hastanesi̇

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Anticipated)

April 13, 2022

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/11-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will be shared as the first patient included in the study

IPD Sharing Time Frame

From 25 december - 3 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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