- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04754113
Effect of Prone Position onV/Q Matching in Non-intubated Patients With COVID-19
Effect of Prone Position on Lung Ventilation and Perfusion Matching in Non-intubated Patients With COVID-19 Pneumonia
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Ling Liu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
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
Sponsor
Investigators
- Study Director: Ling Liu, Zhongda Hospital, School of Medicinr, Southeast Univerty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID-19 PPV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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