Inverse Ratio Ventilation in Neonatal Open Repair of Tracheoesophageal Fistula. (NCT05150600) | Clinical Trial Compass
CompletedNot Applicable
Inverse Ratio Ventilation in Neonatal Open Repair of Tracheoesophageal Fistula.
Egypt40 participantsStarted 2021-10-15
Plain-language summary
Background and Objectives: Maintaining oxygenation during neonatal open repair of esophageal atresia is difficult. Inverse ratio ventilation can be used during one lung ventilation (OLV) to improve the oxygenation and lung mechanics. The investigators will compare inverse ratio to conventional ratio ventilation during OLV in neonatal open repair of esophageal atresia regarding effect in oxygenation, hemodynamic variables, incidence of complications, and easiness of procedure.
Methods: The investigators will enroll 40 term neonates undergoing open right thoracotomy for esophageal atresia repair in this prospective randomized study. The patients will be randomly assigned into 2 groups based on inspiratory to expiratory (I:E) ratio of mechanical ventilation parameters (I:E ratio will be 2:1 in IRV and 1:2 in CRV). The incidence of desaturation episodes that needs to stop the procedure and reinflation of the lung will recorded as the primary outcome while hemodynamic parameters, incidence of complications, and length of surgical procedure will be recorded as the secondary outcomes.
Who can participate
Age range
28 Days
Sex
ALL
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Inclusion Criteria:
* The patients will be of ASA physical status II-III, neonates aged less than 28 days and undergoing open repair of esophageal atresia/tracheoesophageal fistula with right thoracotomy. All patients' will be full term with gestational age ≥ 36 weeks and weigh ≥ 2.5 kilograms.
Exclusion Criteria:
* Significant congenital heart disease including cyanotic heart disease, single ventricle pathology, large intracardiac defect with significant left to right shunt, and severe pulmonary hypertension more than 50 mmHg. Other exclusion criteria included prematurity, pneumonia or severe chest infection prior to the surgery, and parent or guardian refusal.
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.