Inverse Ratio Ventilation in Neonatal Open Repair of Tracheoesophageal Fistula.

NCT05150600 | Completed DMC

• 1 other identifier: FMASU R172/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tracheo Esophageal Fistula

Keywords

Inverse ratio Ventilation; Neonates; Esophageal atresia/Tracheoesophageal fistula; one lung ventilation

Outcome Measures

Primary Outcomes (1)

• Incidence of severe desaturation episodes

  Incidence of desaturation episodes that needs to stop the procedure and reinflation of the retracted lung.

  6 months

Secondary Outcomes (5)

• Mean blood pressure

  6 months

• Incidence of complications

  6 months

• Length of surgical procedure

  6 months

• Heart rate

  6 months

• Oxygen saturation

  6 months

Study Arms (2)

Group Inverse Ratio Ventilation (IRV)

EXPERIMENTAL

The inspiratory to expiratory (I:E) ratio in this group will be 2:1 with the maximum inspiratory time (Ti) of 1.3 seconds

Procedure: Inverse Ratio Ventilation

Group Conventional Ratio Ventilation (CRV)

NO INTERVENTION

The inspiratory to expiratory (I:E) ratio in this group will be 1:2 with the minimum inspiratory time (Ti) of 0.4 seconds

Interventions

Inverse Ratio Ventilation PROCEDURE

The inspiratory to expiratory (I:E) ratio will be reversed to be 2:1 during mechanical ventilation

Group Inverse Ratio Ventilation (IRV)

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university- faculty of medicine- department of anesthesia, intensive care and pain management

Cairo, Egypt

Location

MeSH Terms

Conditions

Tracheoesophageal Fistula

Condition Hierarchy (Ancestors)

Esophageal Fistula; Digestive System Fistula; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Fistula; Respiratory Tract Diseases; Tracheal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Akram Amer, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in the department of Anesthesia

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: December 9, 2021
• Study Start: October 15, 2021
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research. For more information or to submit a request, please contact akram.amer@med.asu.edu.eg

Locations

EG (1)