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CompletedNCT07754591Updated Aug 10, 2026

Comparison of Dynamic Compliance and Airway Resistance in Pressure-Controlled Versus Volume-Controlled Ventilation in Children Undergoing Corrective Heart Surgery

An interventional study of Pressure Controlled Ventilation and Volume Controlled Ventilation in Atrial Septal Defect, Ventricular Septal Defects and Pulmonary Hypertension, sponsored by Nilratan Sircar Medical College. Completed at 1 site in India. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Nilratan Sircar Medical College · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
1 Month to 18 Years
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    Group P - Pressure Controlled Ventilation

    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.

    Other: Pressure Controlled Ventilation

  • Active comparator
    Group V - Volume Controlled Ventilation

    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.

    Other: Volume Controlled Ventilation

Interventions

  • OtherPressure Controlled Ventilation

    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.

    Also known as: PCV

  • OtherVolume Controlled Ventilation

    Mechanical ventilation with tidal volume set at 6-8 mL/kg.

    Also known as: VCV

05

What researchers measure

Primary outcomes

  1. Airway resistance

    Airway resistance derived from ventilator measurements, expressed in cm H2O/L/second

    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

  2. Dynamic compliance

    Dynamic respiratory system compliance derived from ventilator measurements, expressed in mL/cm H2O

    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

  3. PaO2/FiO2 ratio

    Ratio of arterial partial pressure of oxygen to fraction of inspired oxygen, calculated from arterial blood gas analysis, expressed in mmHg

    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

Secondary outcomes

  1. Mean Airway Pressure

    Mean airway pressure derived from ventilator measurements, expressed in cm H2O

    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

06

Study locations

1 site
  • Nil Ratan Sircar Medical College and Hospital
    Kolkata, West Bengal 700014, India
07

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07754591
Lead sponsor
Nilratan Sircar Medical College
Responsible party
Prateek Purkayastha (DM Post-doctoral Trainee, Department of Cardiac Anaesthesia, Nilratan Sircar Medical College) — Principal investigator
First posted
Aug 10, 2026
Start date
Jul 13, 2024
Primary completion
Jul 13, 2025
Completion
Dec 31, 2025
Last update
Aug 10, 2026

Study contacts

Prateek Purkayastha, MBBS, MD
principal investigator · Nilratan Sircar Medical College
Sampa Dutta Gupta, MBBS, MD, PDCC, PhD
study director · Nilratan Sircar Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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