dTDI During a SBT to Predict Extubation Failure in Preterm Infants

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

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.

Study Overview

• Status: Recruiting
• Conditions: Premature
• Intervention / Treatment: Device: diaphragmatic tissue Doppler imaging，dTDI

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jianhui Wang, Doctor; Phone Number: 86-13678428167; Email: wangjh@cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Recruiting
      • Children's Hospital of Chongqing Medical University
      • Contact: Wang Jianhui, Doctor; Phone Number: 13678428167; Email: wangjh@cqmu.edu.cn
      • Principal Investigator: Shuo Tang, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

premature infants with gestational age <32 weeks and supported by invasive mechanical ventilation ≥48 hours

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the failure group; Re-intubation within 48 h after passing the SBT was defined as failed weaning.	Device: diaphragmatic tissue Doppler imaging，dTDI; dTDI was performed at the end of the SBT to assess excursion, velocity, and acceleration.
the success group; Extubation and invasive mechanical ventilation was not needed within 48 h after extubation was defined as successful weaning.	Device: diaphragmatic tissue Doppler imaging，dTDI; dTDI was performed at the end of the SBT to assess excursion, velocity, and acceleration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wang Jianhui

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2023
• Primary Completion (Estimated): November 25, 2024
• Study Completion (Estimated): December 25, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 13, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Premature infants; extubation; diaphragm; tissue Doppler imaging
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: 20230223

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No