Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery

NCT ID: NCT07066748

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2025-12-31

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.

Conditions

Weaning Mechanical Ventilation; Pediatric Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group P: weaning using pressure support ventilation mode

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

Group Type: ACTIVE_COMPARATOR

group P:pressure support ventilation mode

Intervention Type: PROCEDURE

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

group A:Autmated tube compensation mode

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

Group Type: EXPERIMENTAL

group A:automatic tube compensation (ATC).

Intervention Type: PROCEDURE

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

Interventions

group P:pressure support ventilation mode

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

Intervention Type: PROCEDURE

group A:automatic tube compensation (ATC).

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

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Islam Elbardan

LECTURER OF ANESTHESIA AND SURGICALMINTENSIVE CARE

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

Faculty of medicine ,Alexandria university

Alexandria, , Egypt

Countries

Egypt

Central Contacts

ISLAM MOHAMMED ELBARDAN, MD

Role: CONTACT

Islam.elbardan@Alexmed.edu.eg

0020 1112278083

Facility Contacts

Hesham ELgoweini, Prof.Dr.

Role: primary

ethics.comm@alexmed.edu.eg

00201287740750

Other Identifiers

serial number:0307330

Identifier Type: -

Identifier Source: org_study_id