Weaning Mechanical VentilationNCT07066748
Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery
A study testing group P:pressure support ventilation mode and group A:automatic tube compensation (ATC). in people with Weaning Mechanical Ventilation and Pediatric Cardiac Surgery, run by Alexandria University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Weaning Mechanical Ventilation, Pediatric Cardiac Surgery
- What is being tested?
- group P:pressure support ventilation mode and group A:automatic tube compensation (ATC).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 30 Dec 2025
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine ,Alexandria university
Alexandria, Alexandria Governorate, 21521
About this study
Official title: Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery. A Randomized Controlled Trial
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
Read the detailed description
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.
- Being tested
- group P:pressure support ventilation mode, group A:automatic tube compensation (ATC).
- Keywords
- automatic tube compensation, congenital cardiac anomalies
- 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.
group P:pressure support ventilation modeProcedure or surgery
Group P: Weaning trial will be done for patients using PSV 8 cmH2O without ATC
group A:automatic tube compensation (ATC).Procedure or surgery
Group A: Weaning trial will be done for patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC).
| Study group | Role | What they receive |
|---|---|---|
| Group P: weaning using pressure support ventilation mode | Active comparator | Group P: Weaning trial will be done for patients using PSV 8 cmH2O without ATC. Receives: Procedure: group P:pressure support ventilation mode |
| group A:Autmated tube compensation mode | Experimental | Group A: Weaning trial will be done for patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC). Receives: Procedure: group A:automatic tube compensation (ATC). |
What is being measured
The primary outcome is the main question the study is designed to answer.
work of breathing (WOB)
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).
Measured: during weaning trial 30 minutes
Secondary outcomes (4)
lung compliance
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).
Measured: during ventilatory weaning in 30 minutes
Numbers of weaning trials.
Measured: 48 hour post operative
recording the requirement for reintubation and mechanical ventilation
Requirement for reintubation and mechanical ventilation after prior successful weaning from ventilation,
Measured: within 48 hours after extubation
alveolar recruitment
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
Measured: base line immediately before starting weaning trial, every 15 minutes during the weaning trial and 15 minutes after extubating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Aug 2025
- Primary completion28 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Mechanical VentilationStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Elbardan, Alexandria University
- Investigators
- LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066748
- Sponsor's protocol ID
- serial number:0307330
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Mechanical Ventilation After Pediatric Cardiac Surgery. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07066748
- Acronym / sponsor ID
- serial number:0307330
- Keywords
- automatic tube compensation, congenital cardiac anomalies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 28 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 15 Jul 2025 (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.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P: weaning using pressure support ventilation mode | Active comparator | Procedure: group P:pressure support ventilation modeGroup P: Weaning trial will be done for patients using PSV 8 cmH2O without ATC. |
| group A:Autmated tube compensation mode | Experimental | Procedure: group A:automatic tube compensation (ATC).Group A: Weaning trial will be done for patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC). |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| group P:pressure support ventilation modeGroup P: Weaning trial will be done for patients using PSV 8 cmH2O without ATC | Procedure or surgery | Group P: weaning using pressure support ventilation mode |
| group A:automatic tube compensation (ATC).Group A: Weaning trial will be done for patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC). | Procedure or surgery | group A:Autmated tube compensation mode |
Primary outcome
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).
4 secondary outcomes
lung compliance
Time frame: during ventilatory weaning in 30 minutes
Numbers of weaning trials.
Time frame: 48 hour post operative
recording the requirement for reintubation and mechanical ventilation
Time frame: within 48 hours after extubation
alveolar recruitment
Time frame: base line immediately before starting weaning trial, every 15 minutes during the weaning trial and 15 minutes after extubating
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 30 Jul 2026.
- Individual participant dataSharing planned: No
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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.
LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group P:pressure support ventilation mode and group A:automatic tube compensation (ATC). in people with Weaning Mechanical Ventilation and Pediatric Cardiac Surgery, run by Alexandria University 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 4 inclusion and 4 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 30 Jul 2026. 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?
work of breathing (WOB) (time frame: during weaning trial 30 minutes). 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 30 Jul 2026.