NCT05706441

Brief Summary

The goal of this observational study is to learn about the function of lung and diaphragm ultrasound during weaning from mechanical ventilation in COVID-19 patients. The aim of this study was that the lung ultrasound score and diaphragm muscle mobility could be a potential predictive factor of weaning success.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 11, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

April 27, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 18, 2023

Last Update Submit

April 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary end-point was to verify the lung and diaphragm ultrasound evaluation if the predicts weaning success/failure from mechanical ventilation

    Weaning failure was defined as failure to pass the spontaneous-breathing trial or the need for re-intubation within 48 h following extubation

    spontaneous-breathing trial started until 48 hours following extubation

Secondary Outcomes (1)

  • The secondary outcome was to verify the predictive value of the traditional weaning parameters

    spontaneous-breathing trial started until 48 hours following extubation

Study Arms (1)

ultrasound

Pulmonary and diaphragm ultrasound was evaluated within one hour before withdrawal

Other: Point-of-Care Ultrasound

Interventions

Ultrasonographic scans of the lung and right hemidiaphragm were acquired after 30 min from the beginning of the SBT, or immediately before reconnecting the patient to the ventilator in the case of SBT failure occurring before

ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

admission to a COVID-19 ICU with hypoxemic respiratory failure; start of weaning from mechanical ventilation

You may qualify if:

  • age \> 18 years,
  • critically ill patients with COVID-19 (defined as those requiring mechanical ventilation due to respiratory failure), and eligible for their first SBT according to the attending physician's judgement that the underlying disease which led to intubation had sufficiently resolved.

You may not qualify if:

  • patients with previous cardiothoracic surgery or pleurodesis and patients who presented with stridor (due to upper airway involvement) as a cause of extubation failure
  • neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

  • Wang Y, Yi Y, Zhang F, Yao YY, Chen YX, Wu CM, Wang RY, Yan M. Lung Ultrasound Score as a Predictor of Failure to Wean COVID-19 Elderly Patients off Mechanical Ventilation: A Prospective Observational Study. Clin Interv Aging. 2024 Feb 19;19:313-322. doi: 10.2147/CIA.S438714. eCollection 2024.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 31, 2023

Study Start

January 11, 2023

Primary Completion

March 30, 2023

Study Completion

March 30, 2023

Last Updated

April 27, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations