Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery

Not Applicable

Not yet recruiting

• Conditions: Weaning Mechanical Ventilation; Pediatric Cardiac Surgery

• Registration Number: NCT07066748
• Lead Sponsor: Alexandria University

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-04
• Study First Submitted QC: 2025-07-14
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Study Start: 2025-08-01
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Age 2-10years.
2. Both sex.
3. after fulfilling weaning criteria
4. 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

Exclusion Criteria

1. Duration of mechanical ventilation is more than 48 hours
2. Patients on high inotropic support (unstable hemodynamics)
3. Patients with disturbed conscious level
4. Patients with palliative cardiac shunting procedures (e.g., BT shunt, Glenn shunt).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
work of breathing (WOB)	during weaning trial 30 minutes	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).
lung compliance	during ventilatory weaning in 30 minutes	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).
alveolar recruitment	base line immediately before starting weaning trial, every 15 minutes during the weaning trial and 15 minutes after extubating	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

Secondary Outcome Measures

Name	Time	Method
Numbers of weaning trials.	48 hour post operative
recording the requirement for reintubation and mechanical ventilation	within 48 hours after extubation	Requirement for reintubation and mechanical ventilation after prior successful weaning from ventilation,

Trial Locations

Locations (1)

Faculty of medicine ,Alexandria university; 🇪🇬 Alexandria, Egypt