Atrial Septal DefectNCT07754591
Comparison of Dynamic Compliance and Airway Resistance in Pressure-Controlled Versus Volume-Controlled Ventilation in Children Undergoing Corrective Heart Surgery
A study of Atrial Septal Defect and Ventricular Septal Defects, run by Nilratan Sircar Medical College at 1 site in India.
Trial summary
The goal of this clinical trial was to compare two settings on a breathing machine used during heart surgery in children. The children in this study were born with a hole inside the heart. The hole lets extra blood flow to the lungs. Over time this can make the lungs stiffer and harder to inflate. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Atrial Septal Defect, Ventricular Septal Defects, Pulmonary Hypertension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- 13 Jul 2024to 31 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Paediatric patients aged 1 month to 18 years
- Left-to-right intracardiac shunt lesions (atrial septal defect or ventricular septal defect) undergoing corrective surgery under cardiopulmonary bypass - Elevated pulmonary artery pressure: pulmonary artery systolic pressure 30 mmHg or above, and/or mean pulmonary artery pressure 20 mmHg or above
Who cannot join
- Refusal to participate
- Presence of any other associated cardiac anomaly
- Allergy to milrinone
- Associated coagulation disorder
- Sepsis
- Neurological disorder
- Hepatic or renal dysfunction
- Failure to wean from cardiopulmonary bypass
Trial locations and contacts
1 site in 1 country.
India1 site
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014
About this study
Official title: Comparison of Dynamic Compliance and Airway Resistance in Pressure Versus Volume Controlled Ventilation Among Pediatric Patients With Left to Right Intra-Cardiac Shunt Undergoing Corrective Surgery
The goal of this clinical trial was to compare two settings on a breathing machine used during heart surgery in children.
The children in this study were born with a hole inside the heart. The hole lets extra blood flow to the lungs. Over time this can make the lungs stiffer and harder to inflate. All the children had surgery to close the hole, using a heart-lung machine.
Read more
During surgery, a machine breathes for the child. It can be set in two ways. One way controls the pressure of each breath. The other way controls the amount of air in each breath.
The main questions it aimed to answer were:
Which setting kept the lungs easier to inflate during and after surgery? Which setting made it easier for air to move through the breathing tubes? Researchers compared children who got pressure-controlled ventilation with children who got volume-controlled ventilation, to see if lung function differed between the two groups.
Participants:
Had surgery to close the hole in the heart Got one of the two breathing machine settings, chosen at random Had lung measurements taken at eight points, from just after the breathing tube was placed until they were ready to come off the machine.
Read the detailed description
Children with acyanotic left-to-right intracardiac shunt lesions (atrial septal defect or ventricular septal defect) with raised pulmonary artery pressure underwent corrective surgery on cardiopulmonary bypass and were allocated to pressure-controlled or volume-controlled ventilation.
Allocation used pair matching on age, sex and lesion type. One member of each matched pair was assigned by concealed coin toss, and the other was assigned to the alternate group.
Sample size was calculated from the expected difference in mean airway resistance between ventilation modes reported by Tan et al., assuming a standard deviation of 5.82, a between-group difference of 3.9, 5% type I error and 80% power, giving 35 participants per group. Two additional participants were enrolled to allow for protocol deviations or incomplete datasets, giving 36 per group.
Anaesthesia was delivered by a single experienced paediatric cardiac anaesthesiologist so that protocol execution stayed uniform. All intraoperative and postoperative data were recorded by an independent observer blinded to allocation, and analysis used anonymised datasets. The anaesthesiologist managing ventilation could not be blinded to allocation.
Ventilation was standardised across both groups: target tidal volume 6-8 mL/kg, end-tidal carbon dioxide maintained at 35-45 mmHg, positive end-expiratory pressure 4-5 cm H2O, and an inspiratory-to-expiratory ratio of 1:2. Respiratory rate was adjusted to maintain normocapnia and fraction of inspired oxygen was guided by oxygenation status. In the volume-controlled group, tidal volume was set at 6-8 mL/kg. In the pressure-controlled group, inspiratory pressure was titrated to achieve the same tidal volume while keeping peak inspiratory pressure at or below 30 cm H2O.
Respiratory mechanics were recorded at eight predefined perioperative timepoints chosen to represent distinct cardiopulmonary physiological states:
T0: immediate post-intubation T1: ten minutes post-intubation T2: pre-sternotomy T3: pre-bypass T4: immediate post-bypass T5: five minutes after protamine administration T6: post-sternal closure T7: pre-weaning from mechanical ventilation T0 to T3 represented the pre-cross-clamp phase, and T4 to T7 the post-bypass phase. T4 and T5 measurements were taken only after successful separation from bypass, reinstitution of ventilation, restoration of normothermia and haemodynamic stability.
Continuous variables were assessed for normality using the Shapiro-Wilk test. Most perioperative respiratory and haemodynamic variables were non-normally distributed and were expressed as median with interquartile range. Because allocation was pair-matched, matched-pair analysis was used throughout: the Wilcoxon signed-rank test for matched continuous variables and McNemar's test for matched categorical variables, with Benjamini-Hochberg false discovery rate correction applied across repeated perioperative comparisons.
Longitudinal trajectories were additionally modelled using linear mixed-effects models with random patient intercepts, assessing effects of ventilation mode, timepoint, diagnosis, age, body weight, and mode-by-time interaction. All tests were two-tailed with significance at p less than 0.05.
Note I've replaced the en-dashes with hyphens, the subscript ₂ with plain "2", and Shapiro-Wilk/Benjamini-Hochberg dashes with hyphens. PRS is inconsistent with non-ASCII characters and they sometimes come out as mojibake in the public record. Check Preview after saving.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defects, Pulmonary Hypertension, Intracardiac and Septal Defects
- Being tested
- Pressure Controlled Ventilation, Volume Controlled Ventilation
- Keywords
- Pressure-controlled ventilation, Volume-controlled ventilation, Dynamic compliance, Airway resistance, Respiratory mechanics, Pediatric cardiac surgery, Cardiopulmonary bypass, Left-to-right shunt
- Medical subject headings
- Heart Septal Defects, Atrial, Heart Septal Defects, Ventricular, Hypertension, Pulmonary, Heart Septal Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Controlled VentilationOther
Also called PCV
Mechanical ventilation with inspiratory pressure titrated to achieve a tidal volume of 6-8 mL/kg, with peak inspiratory pressure kept at or below 30 cm H2O.
Volume Controlled VentilationOther
Also called VCV
Mechanical ventilation with tidal volume set at 6-8 mL/kg.
| Study group | Role | What they receive |
|---|---|---|
| Group P - Pressure Controlled Ventilation | Active comparator | Inspiratory pressure titrated to achieve a tidal volume of 6-8 mL/kg while keeping peak inspiratory pressure at or below 30 cm H2O, with an inspiratory-to-expiratory ratio of 1:2 and respiratory rate adjusted to maintain end-tidal carbon dioxide at 35-45 mmHg. Receives: Other: Pressure Controlled Ventilation |
| Group V - Volume Controlled Ventilation | Active comparator | Tidal volume set at 6-8 mL/kg, with an inspiratory-to-expiratory ratio of 1:2 and respiratory rate adjusted to maintain end-tidal carbon dioxide at 35-45 mmHg. Receives: Other: Volume Controlled Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway resistance
Airway resistance derived from ventilator measurements, expressed in cm H2O/L/second
Measured: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation
Dynamic compliance
Dynamic respiratory system compliance derived from ventilator measurements, expressed in mL/cm H2O
Measured: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation
PaO2/FiO2 ratio
Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen, calculated from arterial blood gas analysis, expressed in mmHg
Measured: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation
Secondary outcomes (1)
Mean Airway Pressure
Mean airway pressure derived from ventilator measurements, expressed in cm H2O
Measured: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start13 Jul 2024
- Primary completion13 Jul 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal DefectStudies 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
- Model description
- Pair-matched parallel-group design. Participants were matched on age, sex and type of left-to-right intracardiac shunt lesion. One member of each matched pair was allocated by concealed coin toss and the other assigned to the alternate group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nilratan Sircar Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prateek Purkayastha, Nilratan Sircar Medical College
- Investigators
- Prateek Purkayastha, MBBS, MD, Principal investigator, Nilratan Sircar Medical CollegeSampa Dutta Gupta, MBBS, MD, PDCC, PhD, Study director, Nilratan Sircar Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754591
- Sponsor's protocol ID
- NRSMC/IEC/225/2024
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The study was approved by the Institutional Ethics Committee on the basis of a participant information sheet and consent form that provide for confidentiality of health-related information and non-disclosure of participant identity, and which do not include consent for the transfer of individual participant data to third parties. Sharing of IPD would therefore require a protocol amendment and fresh ethics approval, which has not been sought. Aggregate results will be made available through publication.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dynamic Compliance and Airway Resistance in Pressure Versus Volume Controlled Ventilation Among Pediatric Patients With Left to Right Intra-Cardiac Shunt Undergoing Corrective Surgery
- ClinicalTrials.gov ID
- NCT07754591
- Acronym / sponsor ID
- NRSMC/IEC/225/2024
- Conditions
- Atrial Septal Defect, Ventricular Septal Defects, Pulmonary Hypertension, Intracardiac and Septal Defects
- Keywords
- Pressure-controlled ventilation, Volume-controlled ventilation, Dynamic compliance, Airway resistance, Respiratory mechanics, Pediatric cardiac surgery, Cardiopulmonary bypass, Left-to-right shunt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Nilratan Sircar Medical CollegeOther government
- Study start
- 13 Jul 2024 (actual)
- Primary completion
- 13 Jul 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Aug 2026 (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 goal of this clinical trial was to compare two settings on a breathing machine used during heart surgery in children.
The children in this study were born with a hole inside the heart. The hole lets extra blood flow to the lungs. Over time this can make the lungs stiffer and harder to inflate. All the children had surgery to close the hole, using a heart-lung machine.
During surgery, a machine breathes for the child. It can be set in two ways. One way controls the pressure of each breath. The other way controls the amount of air in each breath.
The main questions it aimed to answer were:
Which setting kept the lungs easier to inflate during and after surgery? Which setting made it easier for air to move through the breathing tubes? Researchers compared children who got pressure-controlled ventilation with children who got volume-controlled ventilation, to see if lung function differed between the two groups.
Participants:
Had surgery to close the hole in the heart Got one of the two breathing machine settings, chosen at random Had lung measurements taken at eight points, from just after the breathing tube was placed until they were ready to come off the machine.
Detailed description
Children with acyanotic left-to-right intracardiac shunt lesions (atrial septal defect or ventricular septal defect) with raised pulmonary artery pressure underwent corrective surgery on cardiopulmonary bypass and were allocated to pressure-controlled or volume-controlled ventilation.
Allocation used pair matching on age, sex and lesion type. One member of each matched pair was assigned by concealed coin toss, and the other was assigned to the alternate group.
Sample size was calculated from the expected difference in mean airway resistance between ventilation modes reported by Tan et al., assuming a standard deviation of 5.82, a between-group difference of 3.9, 5% type I error and 80% power, giving 35 participants per group. Two additional participants were enrolled to allow for protocol deviations or incomplete datasets, giving 36 per group.
Anaesthesia was delivered by a single experienced paediatric cardiac anaesthesiologist so that protocol execution stayed uniform. All intraoperative and postoperative data were recorded by an independent observer blinded to allocation, and analysis used anonymised datasets. The anaesthesiologist managing ventilation could not be blinded to allocation.
Ventilation was standardised across both groups: target tidal volume 6-8 mL/kg, end-tidal carbon dioxide maintained at 35-45 mmHg, positive end-expiratory pressure 4-5 cm H2O, and an inspiratory-to-expiratory ratio of 1:2. Respiratory rate was adjusted to maintain normocapnia and fraction of inspired oxygen was guided by oxygenation status. In the volume-controlled group, tidal volume was set at 6-8 mL/kg. In the pressure-controlled group, inspiratory pressure was titrated to achieve the same tidal volume while keeping peak inspiratory pressure at or below 30 cm H2O.
Respiratory mechanics were recorded at eight predefined perioperative timepoints chosen to represent distinct cardiopulmonary physiological states:
T0: immediate post-intubation T1: ten minutes post-intubation T2: pre-sternotomy T3: pre-bypass T4: immediate post-bypass T5: five minutes after protamine administration T6: post-sternal closure T7: pre-weaning from mechanical ventilation T0 to T3 represented the pre-cross-clamp phase, and T4 to T7 the post-bypass phase. T4 and T5 measurements were taken only after successful separation from bypass, reinstitution of ventilation, restoration of normothermia and haemodynamic stability.
Continuous variables were assessed for normality using the Shapiro-Wilk test. Most perioperative respiratory and haemodynamic variables were non-normally distributed and were expressed as median with interquartile range. Because allocation was pair-matched, matched-pair analysis was used throughout: the Wilcoxon signed-rank test for matched continuous variables and McNemar's test for matched categorical variables, with Benjamini-Hochberg false discovery rate correction applied across repeated perioperative comparisons.
Longitudinal trajectories were additionally modelled using linear mixed-effects models with random patient intercepts, assessing effects of ventilation mode, timepoint, diagnosis, age, body weight, and mode-by-time interaction. All tests were two-tailed with significance at p less than 0.05.
Note I've replaced the en-dashes with hyphens, the subscript ₂ with plain "2", and Shapiro-Wilk/Benjamini-Hochberg dashes with hyphens. PRS is inconsistent with non-ASCII characters and they sometimes come out as mojibake in the public record. Check Preview after saving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pair-matched parallel-group design. Participants were matched on age, sex and type of left-to-right intracardiac shunt lesion. One member of each matched pair was allocated by concealed coin toss and the other assigned to the alternate group.
| Arm | Type | Receives |
|---|---|---|
| Group P - Pressure Controlled Ventilation | Active comparator | Other: Pressure Controlled VentilationInspiratory pressure titrated to achieve a tidal volume of 6-8 mL/kg while keeping peak inspiratory pressure at or below 30 cm H2O, with an inspiratory-to-expiratory ratio of 1:2 and respiratory rate adjusted to maintain end-tidal carbon dioxide at 35-45 mmHg. |
| Group V - Volume Controlled Ventilation | Active comparator | Other: Volume Controlled VentilationTidal volume set at 6-8 mL/kg, with an inspiratory-to-expiratory ratio of 1:2 and respiratory rate adjusted to maintain end-tidal carbon dioxide at 35-45 mmHg. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Paediatric patients aged 1 month to 18 years
- Left-to-right intracardiac shunt lesions (atrial septal defect or ventricular septal defect) undergoing corrective surgery under cardiopulmonary bypass - Elevated pulmonary artery pressure: pulmonary artery systolic pressure 30 mmHg or above, and/or mean pulmonary artery pressure 20 mmHg or above
Key exclusion criteria (8 listed)
- Refusal to participate
- Presence of any other associated cardiac anomaly
- Allergy to milrinone
- Associated coagulation disorder
- Sepsis
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 |
|---|---|---|
| Pressure Controlled VentilationAlso: PCVMechanical ventilation with inspiratory pressure titrated to achieve a tidal volume of 6-8 mL/kg, with peak inspiratory pressure kept at or below 30 cm H2O. | Other | Group P - Pressure Controlled Ventilation |
| Volume Controlled VentilationAlso: VCVMechanical ventilation with tidal volume set at 6-8 mL/kg. | Other | Group V - Volume Controlled Ventilation |
Primary outcome
Airway resistance
Time frame: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation
Airway resistance derived from ventilator measurements, expressed in cm H2O/L/second
Dynamic compliance
Time frame: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation
Dynamic respiratory system compliance derived from ventilator measurements, expressed in mL/cm H2O
PaO2/FiO2 ratio
Time frame: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation
Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen, calculated from arterial blood gas analysis, expressed in mmHg
1 secondary outcome
Mean Airway Pressure
Time frame: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation
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 10 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study was approved by the Institutional Ethics Committee on the basis of a participant information sheet and consent form that provide for confidentiality of health-related information and non-disclosure of participant identity, and which do not include consent for the transfer of individual participant data to third parties. Sharing of IPD would therefore require a protocol amendment and fresh ethics approval, which has not been sought. Aggregate results will be made available through publication.
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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.
Prateek Purkayastha, MBBS, MD principal investigator
Nilratan Sircar Medical College
Sampa Dutta Gupta, MBBS, MD, PDCC, PhD study director
Nilratan Sircar Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Atrial Septal Defect and Ventricular Septal Defects, run by Nilratan Sircar Medical College at 1 site in India.
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 2 inclusion and 8 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 10 Aug 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 India. 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?
Airway resistance (time frame: Eight perioperative timepoints: immediate post-intubation, ten minutes post-intubation, pre-sternotomy, pre-bypass, immediate post-bypass, five minutes after protamine administration, post-sternal closure, and pre-weaning from mechanical ventilation). 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 10 Aug 2026.