dTDI During a SBT to Predict Extubation Failure in Preterm Infants

Recruiting

• Conditions: Premature
• Interventions: Device: diaphragmatic tissue Doppler imaging，dTDI

• Registration Number: NCT05865977
• Lead Sponsor: Wang Jianhui

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-25
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-13
• Last Update Posted: 2024-07-16
• Primary Completion: 2024-11-25
• Study Completion: 2024-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the failure group	diaphragmatic tissue Doppler imaging，dTDI	Re-intubation within 48 h after passing the SBT was defined as failed weaning.
the success group	diaphragmatic tissue Doppler imaging，dTDI	Extubation and invasive mechanical ventilation was not needed within 48 h after extubation was defined as successful weaning.

Primary Outcome Measures

Name	Time	Method
Change in diaphragmatic displacement velocity	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 Outcome Measures

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

Trial Locations

Locations (1)

Children's hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China