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Weaning FailureNCT05632822

Value of Diaphragm Function Predicting Weaning From Mechanical Ventilation

An observational study of Weaning Failure and Diaphragm Defect, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The reason of failure of weaning from mechanical ventilation is that their respiratory loads exceeding the capacity of their respiratory muscles. The electric activity of diaphragm (EADI) allows quantification of the neural respiratory drive to the diaphragm. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Weaning Failure, Diaphragm Defect
How many people
25 participants
Where
1 siteChina
Study dates
1 Sep 2022to 1 Jan 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: Patients were intubated and ventilated for at least 48 h, who need to conduct weaning protocol.

Who may be able to join

  • 18 years old Patients with acute respiratory failure and endotracheal intubation Invasive ventilator time ≥48 hours Switched to auxiliary ventilation mode and have weaning plan.

Who cannot join

  • Patients with severe neuromuscular diseases Patients treated with muscle relaxants Patients who have been or are about to be discontinued from life support Patients with esophageal and fundus varicose veins, digestive tract perforation or gastric tube insertion after upper digestive tract surgery contraindicated Pregnant patients.

Trial locations and contacts

1 site in 1 country.

Shitong Diao, Dr contact

13833117878

diaost@foxmail.com

China1 site, 1 recruiting
  • Peking Union Medical College Hospital

    Beijing

    Longfang Miao, 69156874, pumchkyc@126.com

    Recruiting

Other trials in China

About this study

Official title: Predictive Value of Diaphragm Function Monitoring for Weaning in Mechanically Ventilated Patients: a Prospective Observational Cohort Study

The reason of failure of weaning from mechanical ventilation is that their respiratory loads exceeding the capacity of their respiratory muscles. The electric activity of diaphragm (EADI) allows quantification of the neural respiratory drive to the diaphragm. The aim of this study is to evaluate diaphragmatic ultrasound related parameters and electric activity of diaphragm (EADI) during SBT and postural changes to predict weaning outcome.

Read the detailed description

The reason of failure of weaning from mechanical ventilation is that their respiratory loads exceeding the capacity of their respiratory muscles. The aim of this study is to evaluate diaphragmatic ultrasound related parameters and electric activity of diaphragm (EADI) during SBT and postural changes to predict weaning outcome. EADI catheter consists of a nasogastric feeding tube equipped with a multiple-array esophageal electrode that provides real time access to EADI.

Patients intubated and ventilated for at least 48 h were eligible for inclusion in the study.

After the ward physician judged that the patients' condition met the offline standard, patients were prepared to conduct spontaneous breathing trial (SBT). All recruited patients were placed EADI catheter.

The protocol started with patients ventilated on a PSV of 10 cm H2O above a positive end-expiratory pressure (PEEP) of 4-5 cm H2O. Then record ventilator parameters, EADI parameters (including maximum EADI, minimum EADI, area under the curve of the EADI during inspiratory time) and diaphragmatic ultrasound related parameters (diaphragm thickness and diaphragm displacement) respectively in the semi-seated and supine positions. Then assist was removed and a 30-minute SBT was performed with continuous positive airway pressure (CPAP) of 4-5 cm H2O at the previous level of FiO2. At 0, 1, 5, 10, 20 and 30 minutes into the SBT vital signs, ventilatory parameters (including RR, Vt, Ppeak, PEEP, P0.1, MV) were collected. Arterial blood gases were sampled at the start and the end of the SBT.

The SBT was considered to be a failure if at least one the following criteria was present: (1) blood oxygen saturation (SpO2) of <90 % with a fraction of inspired oxygen (FiO2) of≥50 %; (2) acute respiratory distress (RR≥40/min, agitation, cyanosis); (3) systolic arterial blood pressure of ≥180 mmHg; (4) cardiac arrhythmias; (5) respiratory acidosis [pH<7.32 with an arterial carbon dioxide tension (PaCO2) of ≥50 mmHg]. If none of these failure criteria was present, the SBT was considered as successfully completed.

Patient was reconnected if signs of intolerance were present. The separation from the ventilator and the endotracheal tube was considered a success when spontaneous breathing could be sustained without any form of ventilatory support at 48h after extubation. Failure cases included patients who failed the SBT and patients requiring reintubation or any form of ventilator support (including non-invasive ventilation for post-extubation acute respiratory failure) during the first 48 h after extubation.

Keywords
Weaning Failure, Diaphragm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05632822
Study groupRoleWhat they receive
SBT failureThe SBT was considered to be a failure if at least one the following criteria was present: (1) blood oxygen saturation (SpO2) of <90 % with a fraction of inspired oxygen (FiO2) of≥50 %; (2) acute respiratory distress (RR≥40/min, agitation, cyanosis); (3) systolic arterial blood pressure of ≥180 mmHg; (4) cardiac arrhythmias; (5) respiratory acidosis [pH<7.32 with an arterial carbon dioxide tension (PaCO2) of ≥50 mmHg].
SBT successIf none of these failure criteria was present, the SBT was considered as successfully completed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EADI ( diaphragm electrical activity)

    Utilizing NAVA catheter, the EADI allows quantification of the neural respiratory drive to the diaphragm.

    Measured: 30 minutes since SBT was conducted

Secondary outcomes (2)
  1. Diaphragm Neurodisplacement Efficiency

    Diaphragm Neurodisplacement Efficiency (NDE) is the ratio between diaphragm displacement and EAdi. It is uesd to describe the efficiency of EADI transferred to diaphragm displacement.

    Measured: 30 minutes since SBT was conducted

  2. Neuroventilatory Efficiency

    Neuroventilatory Efficiency is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi) .

    Measured: 30 minutes since SBT was conducted

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 Jan 2023 (estimated)

Resources

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
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05632822
Sponsor's protocol ID
K2603
Status last verified
Nov 2022
First submitted
8 Nov 2022
Last updated
1 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Diao S, Li S, Dong R, Jiang W, Wang C, Chen Y, Wang J, He S, Wang Y, Du B, Weng L. The diaphragmatic electrical activity during spontaneous breathing trial in patients with mechanical ventilation: physiological description and potential clinical utility. BMC Pulm Med. 2024 May 30;24(1):263. doi: 10.1186/s12890-024-03077-8.

    PubMed 38816810

Questions about this trial

What is this clinical trial studying?

An observational study of Weaning Failure and Diaphragm Defect, run by Peking Union Medical College Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Dec 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shitong Diao, Dr (13833117878, diaost@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EADI ( diaphragm electrical activity) (time frame: 30 minutes since SBT was conducted). 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 NCT05632822, 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 1 Dec 2022.

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