dTDI During a SBT to Predict Extubation Failure in Preterm Infants
ConditionPremature
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-6
SponsorWang Jianhui
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
accidental extubation
chest CT or bronchoscopy during hospitalization indicated congenital airway dysplasia
complex congenital heart disease
congenital metabolic diseases, neuromuscular diseases
Trial population
premature infants with gestational age \<32 weeks and supported by invasive mechanical ventilation ≥48 hours
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
diaphragmatic tissue Doppler imaging，dTDI
DevicedTDI was performed at the end of the SBT to assess excursion, velocity, and acceleration.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: the failure group1 intervention
Group B: the success group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
an average of 20 minutesSecondary outcomes
1
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.
Time frame
an average of 20 minutes2
Gas exchange - arterial carbon dioxide tension
Arterial blood gases sample
Time frame
through each trial completion, an average of 20 minutes3
Gas exchange - pH
Arterial blood gases sample
Time frame
an average of 20 minutes4
Gas exchange - arterial oxygen tension
Arterial blood gases sample
Time frame
an average of 20 minSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wang Jianhui
Lead sponsor
Children's Hospital of Chongqing Medical University
Sponsor institution
Source ClinicalTrials.gov