"The Protective Effect of Mechanical Ventilation During Cardiopulmonary Bypass in Children Undergoing Fallot Surgery."

: The effect of lung protection ventilation during cardiopulmonary bypass on clinical and laboratory outcomes in children undergoing tetralogy of Fallot surgery.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250316065100N1

Enrollment

Registered

2025-04-09

Start date

2025-04-08

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing surgery for tetralogy of Fallot. Tetralogy of Fallot

Interventions

Intervention 1: Intervention group: "In patients in the intervention group during cardiopulmonary bypass, volume control mode will be used, with a tidal volume of 4-6 ml/kg, an FIO2 of 40%, and a PEEP

Eligibility

Sex/Gender

All

Age

6 Months to 2 Years

Inclusion criteria

Inclusion criteria: Elective patients aged 6 months to 2 years who are candidates for Tetralogy of Fallot surgery

Exclusion criteria

Exclusion criteria: "Patients with unstable hemodynamic status (elevated creatinine, need for ECMO, etc.) during and after the surgery. ""Pump time over 200 minutes and aortic clamp time over 140 minutes.

Design outcomes

Primary

Measure	Time frame
In this study, the duration of ventilation after surgery will be investigated. Timepoint: Postoperative in the intensive care unit. Method of measurement: using the related checklist.;The incidence of lung collapse (atelectasis). Timepoint: 48 hours later in the intensive care unit. Method of measurement: Using the patient's chest X-ray.;Evaluation of The vasoactive inotropic score. Timepoint: 48 hours later in the intensive care unit. Method of measurement: "Using the standard formulas for calculating the doses of dopamine, dobutamine, epinephrine, milrinone, vasopressin, and norepinephrine.	—

Measure

Time frame

In this study, the duration of ventilation after surgery will be investigated. Timepoint: Postoperative in the intensive care unit. Method of measurement: using the related checklist.;The incidence of lung collapse (atelectasis). Timepoint: 48 hours later in the intensive care unit. Method of measurement: Using the patient's chest X-ray.;Evaluation of The vasoactive inotropic score. Timepoint: 48 hours later in the intensive care unit. Method of measurement: "Using the standard formulas for calculating the doses of dopamine, dobutamine, epinephrine, milrinone, vasopressin, and norepinephrine.

—

Secondary

Measure	Time frame
"Duration of hospitalization and intubation in the intensive care unit.". Timepoint: After surgery in the intensive care unit. Method of measurement: Using the patient's file.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Ebrahim Hosseini Zargaz

Shaheed Rajaie Cardiovascular Medical and Research Center

ebrahimhosseini134zargaz@gmail.com+98 21 23921

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026