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

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
prone position
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, prone position, ventilation and perfusion matching

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Ling Liu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

prone position

Arm Description

patients from supine to prone for at least 3 hours than re-supine

Outcomes

Primary Outcome Measures

Ventilation-perfusion (V/Q) mismatch
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).
Ventilation-perfusion (V/Q) mismatch
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).

Secondary Outcome Measures

Regional ventilation
The percentage of relative pixel-level ventilation (Vpixel) distending dorsal lung regions at each study phase
regional perfusion
The pixel-level relative regional pulmonary perfusion
The Global Inhomogeneity (GI) index
higher values indicating less homogenous ventilation
PF raio
PaO2/FiO2

Full Information

First Posted
February 6, 2021
Last Updated
January 21, 2022
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT04754113
Brief Title
Effect of Prone Position onV/Q Matching in Non-intubated Patients With COVID-19
Official Title
Effect of Prone Position on Lung Ventilation and Perfusion Matching in Non-intubated Patients With COVID-19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China

4. Oversight

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

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, prone position, ventilation and perfusion matching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prone position
Arm Type
Experimental
Arm Description
patients from supine to prone for at least 3 hours than re-supine
Intervention Type
Other
Intervention Name(s)
prone position
Intervention Description
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
Primary Outcome Measure Information:
Title
Ventilation-perfusion (V/Q) mismatch
Description
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).
Time Frame
prone position 1 hour
Title
Ventilation-perfusion (V/Q) mismatch
Description
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).
Time Frame
resupination 1 hour
Secondary Outcome Measure Information:
Title
Regional ventilation
Description
The percentage of relative pixel-level ventilation (Vpixel) distending dorsal lung regions at each study phase
Time Frame
Baseline,prone position 1hour, resupination 1 hour
Title
regional perfusion
Description
The pixel-level relative regional pulmonary perfusion
Time Frame
Baseline,prone position 1hour, resupination 1 hour
Title
The Global Inhomogeneity (GI) index
Description
higher values indicating less homogenous ventilation
Time Frame
Baseline,prone position 1hour, resupination 1 hour
Title
PF raio
Description
PaO2/FiO2
Time Frame
Baseline,prone position 1hour, resupination 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 18 to75 years admitted to intensive care unit with a confirmed diagnosis of COVID-19-related pneumonia requiring supplemental oxygen (standard oxygen therapy or high-flow nasal cannula (HFNC)) less than 24 hours, gave written or witnessed verbal informed consent. Exclusion Criteria: uncollaborative or had an altered mental status, New York Heart Association class above II history of severe chronic obstructive pulmonary disease 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) Impending intubation (on the basis of clinical judgment, including clinical and physiological parameters).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Liu
Organizational Affiliation
Zhongda Hospital, School of Medicinr, Southeast Univerty
Official's Role
Study Director
Facility Information:
Facility Name
Ling Liu
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

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

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