Using tissue Doppler imaging to predict extubation failure in premature infants
Diaphragmatic Tissue Doppler Imaging During a Spontaneous Breathing Trial to Predict Extubation Failure in Preterm Infants
This study is testing if measuring how well the diaphragm moves can help doctors predict if premature infants will have trouble breathing on their own after being on a ventilator.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 2 Days to 6 Months |
| Sex | All |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT05865977 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate diaphragmatic function in premature infants undergoing spontaneous breathing trials by measuring diaphragmatic excursion velocity using tissue Doppler imaging. The focus is on infants with a gestational age of less than 32 weeks who have been on mechanical ventilation for at least 48 hours. By analyzing the diaphragm's movement during inspiration and expiration, the study seeks to identify potential predictors of extubation failure. The findings could help improve clinical decision-making regarding extubation in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are premature infants under 32 weeks gestational age who have been on invasive mechanical ventilation for at least 48 hours and meet specific extubation criteria.
Not a fit: Patients who may not benefit from this study include those with complex congenital heart disease, severe brain injury, or other significant comorbidities that complicate extubation.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict extubation failure, potentially reducing complications and improving outcomes for premature infants.
How similar studies have performed: While the use of tissue Doppler imaging in this context is relatively novel, similar approaches in assessing diaphragmatic function have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * give up before extubation; * pneumothorax or pleural effusion * no consent is signed
Where this trial is running
Chongqing, Chongqing Municipality
- Children's hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jianhui Wang, Doctor
- Email: wangjh@cqmu.edu.cn
- Phone: 86-13678428167
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.