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

NCT07754591 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-08-10

No results posted yet for this 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.

Conditions

Interventions

OTHER

Pressure 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.

OTHER

Volume Controlled Ventilation

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

Sponsors & Collaborators

  • Nilratan Sircar Medical College

    lead OTHER_GOV

Principal Investigators

  • Prateek Purkayastha, MBBS, MD · Nilratan Sircar Medical College

  • Sampa Dutta Gupta, MBBS, MD, PDCC, PhD · Nilratan Sircar Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-13
Primary Completion
2025-07-13
Completion
2025-12-31

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754591 on ClinicalTrials.gov