PrematureNCT05865977
dTDI During a SBT to Predict Extubation Failure in Preterm Infants
An observational study of Premature, run by Wang Jianhui at 1 site in China.
Trial summary
Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue… Read more about this study
- Who is it for?
- Ages 2 days to 6 months
- Conditions the study is for
- Premature
- What is being tested?
- diaphragmatic tissue Doppler imaging，dTDI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2023to 25 Dec 2024
- 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 2 days to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: premature infants with gestational age <32 weeks and supported by invasive mechanical ventilation ≥48 hours
Who may be able to join
- premature infants with gestational age <32 weeks and supported by invasive mechanical ventilation ≥48 hours
- All the indications for extubation are met：cough or vomiting due to spontaneous breathing and sputum aspiration; ventilator parameters in recent 24 hours: MAP < 8cmH2O, RR < 30 times/min, FiO2 < 30%; Arterial blood gas: pH > 7.25, (PaCO2< 60mmHg, BE < 8mmol/L, oxygen saturation > 90%
- a successful SBT
- parents or legal guardians sign informed consent to attend this study
Who cannot join
- accidental extubation
- chest CT or bronchoscopy during hospitalization indicated congenital airway dysplasia
- complex congenital heart disease
- congenital metabolic diseases, neuromuscular diseases
- severe brain injury
- surgical mechanical ventilation
Show all 9Show fewer
- give up before extubation;
- pneumothorax or pleural effusion
- no consent is signed
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
Wang Jianhui, Doctor, 13678428167, wangjh@cqmu.edu.cn
Shuo Tang, Master
About this study
Official title: Diaphragmatic Tissue Doppler Imaging During a Spontaneous Breathing Trial to Predict Extubation Failure in Preterm Infants
Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue Doppler analysis in both inspiration and expiration.
- Conditions
- Premature
- Being tested
- diaphragmatic tissue Doppler imaging，dTDI
- Keywords
- tissue Doppler imaging, Premature infants, extubation, diaphragm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragmatic tissue Doppler imaging，dTDIDevice
dTDI was performed at the end of the SBT to assess excursion, velocity, and acceleration.
| Study group | Role | What they receive |
|---|---|---|
| the failure group | Re-intubation within 48 h after passing the SBT was defined as failed weaning. Receives: Device: diaphragmatic tissue Doppler imaging，dTDI | |
| the success group | Extubation and invasive mechanical ventilation was not needed within 48 h after extubation was defined as successful weaning. Receives: Device: diaphragmatic tissue Doppler imaging，dTDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diaphragmatic displacement velocity
Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial and in spontaneous breathing.
Measured: an average of 20 minutes
Secondary outcomes (6)
Diaphragmatic acceleration and deceleration
Diaphragmatic acceleration and deceleration evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial and in spontaneous breathing.
Measured: an average of 20 minutes
Gas exchange - arterial carbon dioxide tension
Arterial blood gases sample
Measured: through each trial completion, an average of 20 minutes
Gas exchange - pH
Arterial blood gases sample
Measured: an average of 20 minutes
Gas exchange - arterial oxygen tension
Arterial blood gases sample
Measured: an average of 20 min
Silverman Andersen Respiratory Severity Score (SA-RSS)
SA-RSS to assess work of breathing after extubation.
Measured: an average of 20 min
Number of patients who experienced weaning failure
the need for non invasive ventilation or re-intubation due to any cause
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start25 Feb 2023
- Primary completion25 Nov 2024 (estimated)
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Jianhui
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Jianhui, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865977
- Sponsor's protocol ID
- 20230223
- Status last verified
- Jul 2024
- First submitted
- 10 May 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Tissue Doppler Imaging During a Spontaneous Breathing Trial to Predict Extubation Failure in Preterm Infants
- ClinicalTrials.gov ID
- NCT05865977
- Acronym / sponsor ID
- 20230223
- Conditions
- Premature
- Keywords
- tissue Doppler imaging, Premature infants, extubation, diaphragm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wang JianhuiUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 25 Nov 2024 (estimated)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 19 May 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.
Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue Doppler analysis in both inspiration and expiration.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the failure group | – | Device: diaphragmatic tissue Doppler imaging，dTDIRe-intubation within 48 h after passing the SBT was defined as failed weaning. |
| the success group | – | Device: diaphragmatic tissue Doppler imaging，dTDIExtubation and invasive mechanical ventilation was not needed within 48 h after extubation was defined as successful weaning. |
Who may qualify
- Ages
- 2 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- premature infants with gestational age <32 weeks and supported by invasive mechanical ventilation ≥48 hours
Key inclusion criteria (4 listed)
- premature infants with gestational age <32 weeks and supported by invasive mechanical ventilation ≥48 hours
- All the indications for extubation are met：cough or vomiting due to spontaneous breathing and sputum aspiration; ventilator parameters in recent 24 hours: MAP < 8cmH2O, RR < 30 times/min, FiO2 < 30%; Arterial blood gas: pH > 7.25, (PaCO2< 60mmHg, BE < 8mmol/L, oxygen saturation > 90%
- a successful SBT
- parents or legal guardians sign informed consent to attend this study
Key exclusion criteria (9 listed)
- accidental extubation
- chest CT or bronchoscopy during hospitalization indicated congenital airway dysplasia
- complex congenital heart disease
- congenital metabolic diseases, neuromuscular diseases
- severe brain injury
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 |
|---|---|---|
| diaphragmatic tissue Doppler imaging，dTDIdTDI was performed at the end of the SBT to assess excursion, velocity, and acceleration. | Device | the failure group, the success group |
Primary outcome
Change in diaphragmatic displacement velocity
Time frame: an average of 20 minutes
Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial and in spontaneous breathing.
6 secondary outcomes
Diaphragmatic acceleration and deceleration
Time frame: an average of 20 minutes
Gas exchange - arterial carbon dioxide tension
Time frame: through each trial completion, an average of 20 minutes
Gas exchange - pH
Time frame: an average of 20 minutes
Gas exchange - arterial oxygen tension
Time frame: an average of 20 min
Silverman Andersen Respiratory Severity Score (SA-RSS)
Time frame: an average of 20 min
Number of patients who experienced weaning failure
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
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 Premature, run by Wang Jianhui 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 4 inclusion and 9 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 16 Jul 2024. 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 Jianhui Wang, Doctor (86-13678428167, wangjh@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diaphragmatic displacement velocity (time frame: an average of 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2024.