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Evaluation of the spontaneous breathing test in predicting the withdrawal from mechanical ventilation after cardiac surgery in children

Evaluation of the efficacy of the spontaneous breathing test in predicting the success of extubation in the postoperative period of cardiac surgery in children: A randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-62h256
Enrollment
Unknown
Registered
2018-07-26
Start date
2013-03-31
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

artificial respiration

Interventions

This was a prospective, randomized, controlled, open trial conducted in the pediatric intensive care unit (PICU) of Hospital das Clínicas of Ribeirão Preto Medical School, University of São Paulo, Bra
c) adequate respiratory drive and appropriate level of consciousness with intact cough and gag reflexes
d) chest X-ray with no signs of significant pulmonary congestion or pleural effusion
e) hemodynamic stability (doses of dopamine < 10 mcg/kg/min or epinephrine < 0.1 mcg/kg/min)
f) absence of bleeding
g) absence of electrolyte disturbance. Exclusion criteria were preoperative mechanical ventilation, uncontrolled pulmonary hypertension and refusal to participate. Patients were evaluated by the atten
Device
E02.041.625.950

Sponsors

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Collaborator

Eligibility

Age
0 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children; aged 0-18 years; with congenital heart disease; admitted to the pediatric intensive care unit after cardiac surgery; receiving mechanical ventilation for more than 12 hours.

Exclusion criteria

Exclusion criteria: preoperative mechanical ventilation; uncontrolled pulmonary hypertension; refusal to participate.

Design outcomes

Primary

MeasureTime frame
Extubation success defined as no need for reintubation within 48 hours after extubation. ;Extubation success was more frequent in patients in the spontaneous breathing trial group compared with the control group (83% vs. 68%, p = 0.02).—

Secondary

MeasureTime frame
Secondary outcomes were PICU length of stay, hospital length of stay, incidence of ventilator-associated pneumonia defined by the 2007 CDC criteria, mortality.;Patients in the spontaneous breathing trial group had a shorter PICU length of stay (hazard ratio 2.96; 95% CI 2-4.28, p<0.01). Duration of mechanical ventilation,hospital length of stay, incidence of ventilator associated pneumonia and mortality were not significantly different in both groups.—

Countries

Brazil

Contacts

Public ContactFelipe Ferreira

Centro de Terapia Intensiva Pediátrica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

fevarella@yahoo.com.br+55-016-991615496

Outcome results

None listed

Source: REBEC (via WHO ICTRP)