Lung and Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in COVID-19 Patients

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05706441

Collaborator

(none)

Enrollment

Location

6.6

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weaning COVID-19 Lung Ultrasound Diaphragm Ultrasound	Other: Point-of-Care Ultrasound

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Lung and Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in COVID-19 Patients：A Prospective, Observational Study

Actual Study Start Date :

Jan 11, 2023

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
ultrasound Pulmonary and diaphragm ultrasound was evaluated within one hour before withdrawal	Other: Point-of-Care Ultrasound Lung and Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation

Arm

Intervention/Treatment

ultrasound

Pulmonary and diaphragm ultrasound was evaluated within one hour before withdrawal

Other: Point-of-Care Ultrasound

Lung and Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation

Outcome Measures

Primary Outcome Measures

The primary end-point was to verify the lung and diaphragm ultrasound evaluation if the predicts weaning success/failure from mechanical ventilation [spontaneous-breathing trial started until 48 hours following extubation]
Weaning failure was defined as failure to pass the spontaneous-breathing trial or the need for re-intubation within 48 h following extubation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age > 18 years,
admission to a COVID-19 ICU with hypoxemic respiratory failure

Exclusion Criteria:

being non-cooperative
patients with previous cardiothoracic surgery or pleurodesis and patients who presented with stridor (due to upper airway involvement) as a cause of extubation failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05706441

Other Study ID Numbers:

2023-0017

First Posted:

Jan 31, 2023

Last Update Posted:

Jan 31, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jan 31, 2023