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Completed

NCT Number: NCT04754113

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

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).

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prone position

Other

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 outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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

  2. regional perfusion

    Time frame: Baseline,prone position 1hour, resupination 1 hour

    The pixel-level relative regional pulmonary perfusion

  3. The Global Inhomogeneity (GI) index

    Time frame: Baseline,prone position 1hour, resupination 1 hour

    higher values indicating less homogenous ventilation

  4. PF raio

    Time frame: Baseline,prone position 1hour, resupination 1 hour

    PaO2/FiO2

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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