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

Wang Jianhui1 site in 1 country100 target enrollmentFebruary 25, 2023

ConditionsPremature

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Premature
Sponsor: Wang Jianhui
Enrollment: 100
Locations: 1
Primary Endpoint: Change in diaphragmatic displacement velocity
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 25, 2023

End Date

December 25, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Wang Jianhui

Responsible Party

Sponsor Investigator

Principal Investigator

Wang Jianhui

Attending doctor

Children's Hospital of Chongqing Medical University

Eligibility 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Number of patients who experienced weaning failure(48 hours)
Silverman Andersen Respiratory Severity Score (SA-RSS)(an average of 20 min)
Gas exchange - arterial carbon dioxide tension(through each trial completion, an average of 20 minutes)
Gas exchange - pH(an average of 20 minutes)
Gas exchange - arterial oxygen tension(an average of 20 min)
Diaphragmatic acceleration and deceleration(an average of 20 minutes)