Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery

NCT07066748 | Not Yet Recruiting

• 1 other identifier: serial number:0307330
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Weaning Mechanical Ventilation; Pediatric Cardiac Surgery

Keywords

automatic tube compensation; congenital cardiac anomalies

Outcome Measures

Primary Outcomes (3)

• 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).

  during weaning trial 30 minutes

• 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).

  during ventilatory weaning in 30 minutes

• 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

  base line immediately before starting weaning trial, every 15 minutes during the weaning trial and 15 minutes after extubating

Secondary Outcomes (2)

• Numbers of weaning trials.

  48 hour post operative

• recording the requirement for reintubation and mechanical ventilation

  within 48 hours after extubation

Study Arms (2)

Group P: weaning using pressure support ventilation mode

ACTIVE COMPARATOR

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

Procedure: group P:pressure support ventilation mode

group A:Autmated tube compensation mode

EXPERIMENTAL

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

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

Interventions

group P:pressure support ventilation mode PROCEDURE

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

Group P: weaning using pressure support ventilation mode

group A:automatic tube compensation (ATC). PROCEDURE

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

group A:Autmated tube compensation mode

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of medicine ,Alexandria university

Alexandria, 21521, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr

  University of Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ISLAM MOHAMMED ELBARDAN, MD

CONTACT

0020 1112278083; Islam.elbardan@Alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER OF ANESTHESIA AND SURGICALMINTENSIVE CARE

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)