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Completed

NCT Number: NCT07066748

Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery

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

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine ,Alexandria university

Alexandria, Alexandria Governorate, 21521, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

group P:pressure support ventilation mode

Procedure

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

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).

Primary outcomes

  1. work of breathing (WOB)

    Time frame: during weaning trial 30 minutes

    Compare the efficacy of ATC versus PS as a modality for ventilatory weaning of paediatric post-cardiac surgery as regards effects on ventilator-derived work of breathing (WOB) (J/L).

Secondary outcomes

  1. lung compliance

    Time frame: 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).

  2. Numbers of weaning trials.

    Time frame: 48 hour post operative

  3. recording the requirement for reintubation and mechanical ventilation

    Time frame: within 48 hours after extubation

    Requirement for reintubation and mechanical ventilation after prior successful weaning from ventilation,

  4. alveolar recruitment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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