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Not Yet RecruitingNCT07066748

Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery

Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery. A Randomized Controlled Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
34 (estimated)
Sponsor
Alexandria University · Academic / Other
Sex
All
Age
2 Years – 10 Years
Healthy volunteers
Not accepted

Summary

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

Detailed description

Different methods have been used to predict the optimum time to make the weaning decision. These methods include, success of spontaneous breathing trials (SBTs), counting respiratory rate, observation of work of breathing, and many other calculated indices such as hypoxic index, oxygenation index, stress index, oxygen reserve index, dynamic compliance, and rapid shallow breathing index (RSBI). However, some of these indices may be misleading and not precise. Pressure support ventilation (PSV) has been widely used in the performance of a spontaneous breathing trial because it can compensate to some extent for the additional work of breathing imposed by the endotracheal tube and the breathing circuit. However, it is difficult to recognize the exact pressure support to overcome the tubing resistance during the weaning process till extubating. The ventilator modality of automatic tube compensation (ATC) can provide variable pressure supports during the weaning process to overcome any change in the resistance of the breathing circuit, endotracheal tube, and airways. ATC is effective in overcoming the work of breathing caused by airway resistance to allow successful weaning process and extubating. Several studies have investigated the effectiveness of ATC and PS for ventilatory weaning in adult patients, with conflicting results. Fewer studies have focused on the pediatric population, and even fewer have specifically examined patients who have undergone cardiac surgery. Therefore, there is a need for further research to determine the most effective weaning mode for this patient population.

Conditions

Interventions

TypeNameDescription
PROCEDUREgroup P:pressure support ventilation modeGroup P: Weaning trial will be done for patients using PSV 8 cmH2O without ATC
PROCEDUREgroup A:automatic tube compensation (ATC).Group A: Weaning trial will be done for patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC).

Timeline

Start date
2025-08-01
Primary completion
2025-12-01
Completion
2025-12-01
First posted
2025-07-15
Last updated
2025-07-15

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07066748. Inclusion in this directory is not an endorsement.