WeaningNCT05706441
Lung and Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in COVID-19 Patients
An observational study of Weaning and COVID-19, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning, COVID-19, Lung Ultrasound
- What is being tested?
- Point-of-Care Ultrasound
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2023to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: admission to a COVID-19 ICU with hypoxemic respiratory failure； start of weaning from mechanical ventilation
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
About this study
Official title: 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.
- Conditions
- Weaning, COVID-19, Lung Ultrasound, Diaphragm Ultrasound
- Being tested
- Point-of-Care Ultrasound
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care UltrasoundOther
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
| Study group | Role | What they receive |
|---|---|---|
| ultrasound | Pulmonary and diaphragm ultrasound was evaluated within one hour before withdrawal Receives: Other: Point-of-Care Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Weaning failure was defined as failure to pass the spontaneous-breathing trial or the need for re-intubation within 48 h following extubation
Measured: spontaneous-breathing trial started until 48 hours following extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start11 Jan 2023
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WeaningStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706441
- Sponsor's protocol ID
- 2023-0017
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38404479
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung and Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in COVID-19 Patients：A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05706441
- Acronym / sponsor ID
- 2023-0017
- Conditions
- Weaning, COVID-19, Lung Ultrasound, Diaphragm Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound | – | Other: Point-of-Care UltrasoundPulmonary and diaphragm ultrasound was evaluated within one hour before withdrawal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- admission to a COVID-19 ICU with hypoxemic respiratory failure； start of weaning from mechanical ventilation
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-Care UltrasoundUltrasonographic 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 | Other | ultrasound |
Primary outcome
The primary end-point was to verify the lung and diaphragm ultrasound evaluation if the predicts weaning success/failure from mechanical ventilation
Time frame: 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
1 secondary outcome
The secondary outcome was to verify the predictive value of the traditional weaning parameters
Time frame: spontaneous-breathing trial started until 48 hours following extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Derived from this study: PubMed 38404479Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning and COVID-19, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end-point was to verify the lung and diaphragm ultrasound evaluation if the predicts weaning success/failure from mechanical ventilation (time frame: spontaneous-breathing trial started until 48 hours following extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.