ATC Vs PSV for Ventilatory Weaning of Pediatrics Postcardiac Surgery

Automatic Tube Compensation Versus Pressure Support for Ventilatory Weaning of Pediatrics Postcardiac Surgery

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. The aim of the study is to evaluate the automatic tube compensation (ATC) as a tool for ventilatory weaning in pediatrics after surgeries for congenital cardiac anomalies.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Other: Weaning from mechanical ventilation

Detailed Description

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 extubation. 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 recognise the exact pressure support to overcome the tubing resistance during the weaning process till extubation. The aim of the study is to evaluate the automatic tube compensation (ATC) as a tool for ventilatory weaning in pediatrics after surgeries for congenital cardiac anomalies. The primary objective of our study is to compare the efficacy of ATC versus PS as a modality for ventilatory weaning of pediatric postcardiac surgery as regards effects on work of breathing, lung compliance, and alveolar recruitment. The secondary objective is to determine perioperative predictors of extubation failure (requirement for reintubation and mechanical ventilation after prior successful weaning from ventilation, within 48 hours after extubation) after cardiac surgery. Patients will be included after fulfilling weaning criteria and being pain free. a weaning trial for 30 minutes will be commenced according to the following and assessed by the attending physician:- Group A: Weaning trial will be done for 17 patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC).

Group P: Weaning trial will be done for 17 patients using PSV 8 cmH2O without ATC.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 23541
    • Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• pediatric patients (age 8 months to 12 years) who will undergo congenital cardiac surgeries with the same general anesthetic technique and Pecto-intercostal fascial plane block (PIFB) as regional analgesia for pain management.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Weaning trial will be done for 17 patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC).	Other: Weaning from mechanical ventilation; Weaning from mechanical ventilation post congenital cardiac surgery
Active Comparator: Group B; Weaning trial will be done for 17 patients using PSV 8 cmH2O without ATC.	Other: Weaning from mechanical ventilation; Weaning from mechanical ventilation post congenital cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minute ventilation	Tidal volume (ml/kg) × respiratory rate (breath / minutes)	1 year
Oxygenation index (OI)	mean air way pressure × FIO2/PaO2	1 year
Work of breathing (WOB)	(∆ V × flow × R + Volume/compliance) (J/L/Kg)	1 year

Collaborators and Investigators

• Sponsor: University of Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 29, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 193

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No