Actively Recruiting
Diaphragmatic Tissue Doppler Imaging During a Spontaneous Breathing Trial to Predict Extubation Failure in Preterm Infants
Led by Wang Jianhui · Updated on 2024-07-16
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of diaphragmatic tissue Doppler imaging (dTDI) to study diaphragmatic excursion velocity in premature infants during a spontaneous breathing trial (SBT). The goal is to understand how diaphragm movement relates to the success or failure of weaning from mechanical ventilation. This observational study focuses on preterm infants supported by invasive mechanical ventilation for at least 48 hours and aims to predict extubation failure, which is a critical issue linked to diaphragmatic dysfunction. During the study, dTDI is performed at the end of the SBT to assess the diaphragm's excursion, velocity, and acceleration in both inspiration and expiration phases. Patients are grouped based on their success or failure during weaning: those who require re-intubation within 48 hours after passing the SBT are considered to have failed weaning, while those who do not require invasive ventilation within 48 hours after extubation are considered successful. The main focus is on measuring changes in diaphragmatic displacement velocity over an average of 20 minutes. Participants are monitored for various outcomes including diaphragmatic acceleration and deceleration, gas exchange parameters like arterial carbon dioxide tension, pH, and oxygen tension, as well as respiratory severity scores. The study closely observes the number of patients experiencing weaning failure within 48 hours. Data collection occurs during the SBT and throughout the 48-hour post-extubation period, with parental consent required for participation. The study is led by Wang Jianhui and is ongoing until December 25, 2024.
CONDITIONS
Brief Title
dTDI During a SBT to Predict Extubation Failure in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premature infants with gestational age less than 32 weeks
- Supported by invasive mechanical ventilation for at least 48 hours
- Meet all indications for extubation including cough or vomiting due to spontaneous breathing and sputum aspiration
- Ventilator parameters in recent 24 hours: mean airway pressure less than 8 cmH2O, respiratory rate less than 30 times per minute, fraction of inspired oxygen less than 30%
- Arterial blood gas values: pH greater than 7.25, arterial carbon dioxide tension less than 60 mmHg, base excess less than 8 mmol/L, oxygen saturation greater than 90%
- Successful spontaneous breathing trial
- Parents or legal guardians have signed informed consent to attend the study
You will not qualify if you...
- Accidental extubation
- Chest CT or bronchoscopy during hospitalization indicating congenital airway dysplasia
- Complex congenital heart disease
- Congenital metabolic diseases or neuromuscular diseases
- Severe brain injury
- Surgical mechanical ventilation
- Giving up before extubation
- Pneumothorax or pleural effusion
- No consent signed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 minutes
Participants undergo diaphragmatic tissue Doppler imaging (dTDI) at the end of a spontaneous breathing trial to assess diaphragmatic function.
1 visit (in-person)
Duration - 48 hours
Participants are observed for 48 hours after extubation to determine weaning success or failure based on clinical outcomes.
Continuous monitoring during hospitalization
Trial Site Locations
Total: 1 location
1
Children's hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400014
Actively Recruiting
Research Team
J
Jianhui Wang, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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