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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05865977
Enrollment
100
Registered
2023-05-19
Start date
2023-02-25
Completion date
2024-12-25
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature

Keywords

tissue Doppler imaging, Premature infants, extubation, diaphragm

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.

Interventions

DEVICEdiaphragmatic tissue Doppler imaging,dTDI

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

Sponsors

Wang Jianhui
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Days to 6 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in diaphragmatic displacement velocityan average of 20 minutesInspiratory 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

MeasureTime frameDescription
Gas exchange - arterial carbon dioxide tensionthrough each trial completion, an average of 20 minutesArterial blood gases sample
Gas exchange - pHan average of 20 minutesArterial blood gases sample
Diaphragmatic acceleration and decelerationan average of 20 minutesDiaphragmatic 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.
Silverman Andersen Respiratory Severity Score (SA-RSS)an average of 20 minSA-RSS to assess work of breathing after extubation.
Number of patients who experienced weaning failure48 hoursthe need for non invasive ventilation or re-intubation due to any cause
Gas exchange - arterial oxygen tensionan average of 20 minArterial blood gases sample

Countries

China

Contacts

Primary ContactJianhui Wang, Doctor
wangjh@cqmu.edu.cn86-13678428167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026