Effect of Prone Position onV/Q Matching in Non-intubated Patients With COVID-19

January 21, 2022 updated by: Ling Liu, Southeast University, China

Effect of Prone Position on Lung Ventilation and Perfusion Matching in Non-intubated Patients With COVID-19 Pneumonia

A prospective physiologic study, in participants with COVID-19-related pneumonia requiring supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (HFNC)) less than 24 hours. The investigators assessed the effect of prone position on ventilation inhomogeneity and ventilation/perfusion mismatch by electrical impedance tomography (EIT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Once enrolled, an EIT dedicated belt containing 16 electrodes was placed around the participant's chest at the fifth or sixth intercostal space and connected it to an EIT monitor (PulmoVista 500; Dräger Medical GmbH, Lübeck, Germany).

Baseline data were collected during supine position (timepoint SP1), including demographic and anthropometric data, a baseline arterial blood gas measurement, and ventilation parameters including type of supplemental oxygen, respiratory rate, fractional concentration of oxygen in inspired air (FiO2). The participants received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 5% NaCl solution was injected via the central venous catheter. Subsequently, each participant was helped into the prone position and data collection,end expiratory occlusion and 10% NaCl solution injection were preformed again after approximately 30 min (timepoint PP1). The participant was then encouraged to maintain the prone position for at least 3 h before being helped back into the supine position. Clinical data collection, end expiratory occlusion and injection of a bolus of 10 mL of 5% NaCl solution were repeated again 1 h after resupination (timepoint SP2).

Study Type

Interventional

Enrollment (Actual)

14

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 Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Ling Liu

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. aged 18 to75 years
  2. admitted to intensive care unit with a confirmed diagnosis of COVID-19-related pneumonia
  3. requiring supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (HFNC)) less than 24 hours,
  4. gave written or witnessed verbal informed consent.

Exclusion Criteria:

  1. uncollaborative or had an altered mental status,
  2. New York Heart Association class above II
  3. history of severe chronic obstructive pulmonary disease
  4. Contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing) or prone position (as decided by the attending physician)
  5. Impending intubation (on the basis of clinical judgment, including clinical and physiological parameters).

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prone position
patients from supine to prone for at least 3 hours than re-supine
patient was helped into the prone position, patient received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 5% NaCl solution was injected via the central venous catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilation-perfusion (V/Q) mismatch
Time Frame: prone position 1 hour
V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated but not perfused (dead space fraction) plus the percentage of those perfused but not ventilated (shunt fraction).
prone position 1 hour
Ventilation-perfusion (V/Q) mismatch
Time Frame: resupination 1 hour
V/Q mismatch was quantified as the percentage of pixels that were classified as ventilated but not perfused (dead space fraction) plus the percentage of those perfused but not ventilated (shunt fraction).
resupination 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional ventilation
Time Frame: Baseline,prone position 1hour, resupination 1 hour
The percentage of relative pixel-level ventilation (Vpixel) distending dorsal lung regions at each study phase
Baseline,prone position 1hour, resupination 1 hour
regional perfusion
Time Frame: Baseline,prone position 1hour, resupination 1 hour
The pixel-level relative regional pulmonary perfusion
Baseline,prone position 1hour, resupination 1 hour
The Global Inhomogeneity (GI) index
Time Frame: Baseline,prone position 1hour, resupination 1 hour
higher values indicating less homogenous ventilation
Baseline,prone position 1hour, resupination 1 hour
PF raio
Time Frame: Baseline,prone position 1hour, resupination 1 hour
PaO2/FiO2
Baseline,prone position 1hour, resupination 1 hour

Collaborators and Investigators

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

Investigators

  • Study Director: Ling Liu, Zhongda Hospital, School of Medicinr, Southeast Univerty

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)

February 8, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 15, 2022

Study Registration Dates

First Submitted

February 6, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 21, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

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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