dTDI During a SBT to Predict Extubation Failure in Preterm Infants

Sponsor

Wang Jianhui (Other)

Overall Status

Recruiting

CT.gov ID

NCT05865977

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature	Device: diaphragmatic tissue Doppler imaging，dTDI

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 25, 2023

Anticipated Primary Completion Date :

Aug 25, 2023

Anticipated Study Completion Date :

Dec 25, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

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.
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
Silverman Andersen Respiratory Severity Score (SA-RSS) [an average of 20 min]
SA-RSS to assess work of breathing after extubation.
Number of patients who experienced weaning failure [48 hours]
the need for non invasive ventilation or re-intubation due to any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Days to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's hospital of Chongqing Medical University	Chongqing	Chongqing	China	400014

Sponsors and Collaborators

Wang Jianhui

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wang Jianhui, Attending doctor, Children's Hospital of Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT05865977

Other Study ID Numbers:

20230223

First Posted:

May 19, 2023

Last Update Posted:

May 19, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wang Jianhui, Attending doctor, Children's Hospital of Chongqing Medical University

tissue Doppler imaging

Premature infants

extubation

diaphragm

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of May 19, 2023