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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754113
• Other study ID #: COVID-19 PPV
• Status: Completed
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: January 2022
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 15, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• prone position
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

Locations

Country	Name	City	State
China	Ling Liu	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

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