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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Weaning; Lung Ultrasound; Diaphragm Ultrasound
• Intervention / Treatment: Other: Point-of-Care Ultrasound

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University anesthesiology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ultrasound; Pulmonary and diaphragm ultrasound was evaluated within one hour before withdrawal	Other: Point-of-Care Ultrasound; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary outcome was to verify the predictive value of the traditional weaning parameters	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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2023-0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No