Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery

Alexandria University

Status: Not yet enrolling

Conditions: Pediatric Cardiac Surgery; Weaning Mechanical Ventilation

Treatments: Procedure: group P:pressure support ventilation mode; Procedure: group A:automatic tube compensation (ATC).

Study type: Interventional

Funder types: Other

Identifiers

NCT07066748

serial number:0307330

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Group P: weaning using pressure support ventilation mode

Active Comparator group

Description:

Group P: Weaning trial will be done for patients using PSV 8 cmH2O without ATC.

Treatment:

Procedure: group P:pressure support ventilation mode

group A:Autmated tube compensation mode

Experimental group

Description:

Group A: Weaning trial will be done for patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC).

Treatment:

Procedure: group A:automatic tube compensation (ATC).