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

NCT07754591 | Completed

• 1 other identifier: NRSMC/IEC/225/2024
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• Airway resistance

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

  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

  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

  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

  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

Study Arms (2)

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.

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.

Other: Volume Controlled Ventilation

Interventions

Pressure Controlled Ventilation OTHER

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

Group P - Pressure Controlled Ventilation

Volume Controlled Ventilation OTHER

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

Also known as: VCV

Group V - Volume Controlled Ventilation

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nilratan Sircar Medical College: lead

Study Sites (1)

Nil Ratan Sircar Medical College and Hospital

Kolkata, West Bengal, 700014, India

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial; Heart Septal Defects, Ventricular; Hypertension, Pulmonary; Heart Septal Defects

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Officials

• Prateek Purkayastha, MBBS, MD

  Nilratan Sircar Medical College

  PRINCIPAL INVESTIGATOR

• Sampa Dutta Gupta, MBBS, MD, PDCC, PhD

  Nilratan Sircar Medical College

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Intraoperative and postoperative data were recorded by an independent observer blinded to group allocation, and analysis used anonymised datasets. The anaesthesiologist managing ventilation could not be blinded, since ventilator settings are visible during use.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DM Post-doctoral Trainee, Department of Cardiac Anaesthesia

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: July 13, 2024
• Primary Completion: July 13, 2025
• Study Completion: December 31, 2025
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)