Congenital Heart DiseaseNCT05344872
ATC Vs PSV for Ventilatory Weaning of Pediatrics Postcardiac Surgery
A study testing Weaning from mechanical ventilation in people with Congenital Heart Disease, run by University of Alexandria at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 months to 12 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Weaning from mechanical ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2022to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- (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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Weaning from mechanical ventilation
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weaning from mechanical ventilationOther
Weaning from mechanical ventilation post congenital cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Weaning trial will be done for 17 patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC). Receives: Other: Weaning from mechanical ventilation |
| Group B | Active comparator | Weaning trial will be done for 17 patients using PSV 8 cmH2O without ATC. Receives: Other: Weaning from mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minute ventilation
Tidal volume (ml/kg) × respiratory rate (breath / minutes)
Measured: 1 year
Oxygenation index (OI)
mean air way pressure × FIO2/PaO2
Measured: 1 year
Work of breathing (WOB)
(∆ V × flow × R + Volume/compliance) (J/L/Kg)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start15 Apr 2022
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344872
- Sponsor's protocol ID
- 193
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Tube Compensation Versus Pressure Support for Ventilatory Weaning of Pediatrics Postcardiac Surgery
- ClinicalTrials.gov ID
- NCT05344872
- Acronym / sponsor ID
- 193
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Weaning from mechanical ventilationWeaning trial will be done for 17 patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC). |
| Group B | Active comparator | Other: Weaning from mechanical ventilationWeaning trial will be done for 17 patients using PSV 8 cmH2O without ATC. |
Who may qualify
- Ages
- 8 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weaning from mechanical ventilationWeaning from mechanical ventilation post congenital cardiac surgery | Other | Group A, Group B |
Primary outcome
Minute ventilation
Time frame: 1 year
Tidal volume (ml/kg) × respiratory rate (breath / minutes)
Oxygenation index (OI)
Time frame: 1 year
mean air way pressure × FIO2/PaO2
Work of breathing (WOB)
Time frame: 1 year
(∆ V × flow × R + Volume/compliance) (J/L/Kg)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weaning from mechanical ventilation in people with Congenital Heart Disease, run by University of Alexandria at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minute ventilation (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.