NCT04754113

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

February 6, 2021

Last Update Submit

January 21, 2022

Conditions

Covid19

Keywords

COVID-19prone positionventilation and perfusion matching

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Regional ventilation

    Baseline，prone position 1hour, resupination 1 hour

  • regional perfusion

    Baseline，prone position 1hour, resupination 1 hour

  • The Global Inhomogeneity (GI) index

    Baseline，prone position 1hour, resupination 1 hour

  • PF raio

    Baseline，prone position 1hour, resupination 1 hour

Study Arms (1)

prone position

EXPERIMENTAL

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

Other: prone position

Interventions

prone positionOTHER

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

prone position

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ling Liu

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

  • Chao Y, Yuan X, Zhao Z, Frerichs I, Li Z, Sun Q, Chen D, Zhang R, Qiu H, Liu L. Physiologic effects of prone positioning on gas exchange and ventilation-perfusion matching in awake patients with AHRF. BMC Pulm Med. 2024 Dec 4;24(1):600. doi: 10.1186/s12890-024-03411-0.

    PMID: 39663512DERIVED

MeSH Terms

Conditions

COVID-19Respiratory Aspiration

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ling Liu

    Zhongda Hospital, School of Medicinr, Southeast Univerty

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 15, 2021

Study Start

February 8, 2021

Primary Completion

January 1, 2022

Study Completion

January 15, 2022

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

CN(1)