NCT05344872

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

April 18, 2022

Last Update Submit

April 29, 2023

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Other: Weaning from mechanical ventilation

Group B

ACTIVE COMPARATOR

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

Other: Weaning from mechanical ventilation

Interventions

Weaning from mechanical ventilationOTHER

Weaning from mechanical ventilation post congenital cardiac surgery

Group AGroup B

Eligibility Criteria

Age8 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • (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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, 23541, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 25, 2022

Study Start

April 15, 2022

Primary Completion

January 25, 2023

Study Completion

January 25, 2023

Last Updated

May 3, 2023

Record last verified: 2022-04

Locations

EG(1)