dTDI During a SBT to Predict Extubation Failure in Preterm Infants

NCT ID: NCT05865977

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-25

Study Completion Date

2024-12-25

Brief Summary

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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

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Conditions

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Premature

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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the failure group

Re-intubation within 48 h after passing the SBT was defined as failed weaning.

diaphragmatic tissue Doppler imaging,dTDI

Intervention Type DEVICE

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.

diaphragmatic tissue Doppler imaging,dTDI

Intervention Type DEVICE

dTDI was performed at the end of the SBT to assess excursion, velocity, and acceleration.

Interventions

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diaphragmatic tissue Doppler imaging,dTDI

dTDI was performed at the end of the SBT to assess excursion, velocity, and acceleration.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

2 Days

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wang Jianhui

OTHER

Sponsor Role lead

Responsible Party

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Wang Jianhui

Attending doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Children's hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianhui Wang, Doctor

Role: CONTACT

86-13678428167

Facility Contacts

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Wang Jianhui, Doctor

Role: primary

13678428167

Other Identifiers

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20230223

Identifier Type: -

Identifier Source: org_study_id

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