Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014, India
NCT Number: NCT07754591
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.
Looking for future studies?
Notify Me1 month–18 year
All sexes
Interventional
Not applicable
Kolkata, West Bengal, 700014, India
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: PCV
Mechanical ventilation with tidal volume set at 6-8 mL/kg.
Other names: VCV
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
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
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
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
Mean airway pressure derived from ventilator measurements, expressed in cm H2O
Nilratan Sircar Medical College
Other Gov
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
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