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ATC Vs PSV for Ventilatory Weaning of Pediatrics Postcardiac Surgery

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Weaning from mechanical ventilation
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease

Eligibility Criteria

8 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Alexandria university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

Weaning trial will be done for 17 patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 18, 2022
Last Updated
April 29, 2023
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT05344872
Brief Title
ATC Vs PSV for Ventilatory Weaning of Pediatrics Postcardiac Surgery
Official Title
Automatic Tube Compensation Versus Pressure Support for Ventilatory Weaning of Pediatrics Postcardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
January 25, 2023 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alexandria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Weaning trial will be done for 17 patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC).
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Weaning trial will be done for 17 patients using PSV 8 cmH2O without ATC.
Intervention Type
Other
Intervention Name(s)
Weaning from mechanical ventilation
Intervention Description
Weaning from mechanical ventilation post congenital cardiac surgery
Primary Outcome Measure Information:
Title
Minute ventilation
Description
Tidal volume (ml/kg) × respiratory rate (breath / minutes)
Time Frame
1 year
Title
Oxygenation index (OI)
Description
mean air way pressure × FIO2/PaO2
Time Frame
1 year
Title
Work of breathing (WOB)
Description
(∆ V × flow × R + Volume/compliance) (J/L/Kg)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Alexandria university
City
Alexandria
ZIP/Postal Code
23541
Country
Egypt

12. IPD Sharing Statement

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ATC Vs PSV for Ventilatory Weaning of Pediatrics Postcardiac Surgery

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