dTDI During a SBT to Predict Extubation Failure in Preterm Infants

Premature Clinical Trial

Official title:

Diaphragmatic Tissue Doppler Imaging During a Spontaneous Breathing Trial to Predict Extubation Failure in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05865977
• Other study ID #: 20230223
• Status: Recruiting
• Start date: February 25, 2023
• Est. completion date: June 25, 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital of Chongqing Medical University
• Contact: Jianhui Wang, Doctor
• Phone: 86-13678428167
• Email: wangjh[@]cqmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 Doppler analysis in both inspiration and expiration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 25, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Days to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Premature
• Premature Birth

Intervention

Device:
• diaphragmatic tissue Doppler imaging,dTDI
dTDI was performed at the end of the SBT to assess excursion, velocity, and acceleration.

Locations

Country	Name	City	State
China	Children's hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Wang Jianhui

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	an average of 20 minutes
Secondary	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.	an average of 20 minutes
Secondary	Gas exchange - arterial carbon dioxide tension	Arterial blood gases sample	through each trial completion, an average of 20 minutes
Secondary	Gas exchange - pH	Arterial blood gases sample	an average of 20 minutes
Secondary	Gas exchange - arterial oxygen tension	Arterial blood gases sample	an average of 20 min
Secondary	Silverman Andersen Respiratory Severity Score (SA-RSS)	SA-RSS to assess work of breathing after extubation.	an average of 20 min
Secondary	Number of patients who experienced weaning failure	the need for non invasive ventilation or re-intubation due to any cause	48 hours