Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-10
SponsorAlexandria University
About this trial
Weaning from mechanical ventilation post congenital cardiac surgery is often challenging. It is well known that not all patients can be early extubated, although most are suitable for early postoperative weaning and extubating despite complex operative procedures. With advances in anaesthesia management, cardiopulmonary bypass (CPB), and surgical techniques, the trend of 'fast tracking', and early extubating of pediatrics postcardiac surgery seems to be feasible. Unnecessary prolonged mechanical ventilation increases the complication risks as airway trauma, ventilator associated pneumonia, and increased hospital stay
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 2-10years.
Both sex.
after fulfilling weaning criteria
being pain free (observational pain/discomfort scale < 4). the weaning criteria; which include: low mandatory ventilator rate [6-8] or less; fraction of inspired oxygen (FIO2) ≤ 40; level of positive end expiratory pressure (PEEP) [3-5 cmH2O] guided by pressure/volume loop; reversal of the cause of postoperative mechanical ventilation; oxygenation index (OI) (mean air way pressure × FIO2/PaO2) < 5; dynamic compliance (Cdyn) > 1 ml/ cmH2O/kg
Disqualifiers
Duration of mechanical ventilation is more than 48 hours
Patients on high inotropic support (unstable hemodynamics)
Patients with disturbed conscious level
Patients with palliative cardiac shunting procedures (e.g., BT shunt, Glenn shunt).
Trial design
Design model
Parallel
Treatments tested in this trial
group P:pressure support ventilation mode
Procedure/SurgeryGroup P: Weaning trial will be done for patients using PSV 8 cmH2O without ATC
group A:automatic tube compensation (ATC).
Procedure/SurgeryGroup A: Weaning trial will be done for patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC).
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Group P: weaning using pressure support ventilation modeActive comparator 1 intervention
Group B: group A:Autmated tube compensation modeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
work of breathing (WOB)
compare the efficacy of ATC versus PS as a modality for ventilatory weaning of pediatric postcardiac surgery as regards effects on work of breathing, (WOB) (∆ V × flow × R + Volume/compliance) (J/L/Kg).
Time frame
during weaning trial 30 minutes2
lung compliance
to compare the efficacy of ATC versus PS as a modality for ventilatory weaning of pediatric postcardiac surgery as regards effects on lung compliance. Dynamic compliance (Cdyn) (ml/cmH2O/kg).
Time frame
during ventilatory weaning in 30 minutes3
alveolar recruitment
by Ultrasound lung aeration score: assessment of the lung atelectasis by the lung ultrasound examination, six basic regions will be assessed for each lung. Each hemithorax is divided into anterior, lateral and posterior regions by the anterior and posterior axillary lines. The regions are further subdivided into upper and lower areas. Characteristics Points Normal aeration or less than 2 isolated B lines 0 Moderate loss of aeration with multiple, well-defined B-lines 1 Severe loss of aeration with multiple coalescent B-lines 2 Lung consolidation 3
Time frame
base line immediately before starting weaning trial, every 15 minutes during the weaning trial and 15 minutes after extubatingSecondary outcomes
1
Numbers of weaning trials.
Time frame
48 hour post operative2
recording the requirement for reintubation and mechanical ventilation
Requirement for reintubation and mechanical ventilation after prior successful weaning from ventilation,
Time frame
within 48 hours after extubationSponsors and contacts
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Source ClinicalTrials.gov
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