Umbilical Vein Needle Catheterization for Endotracheal Intubation.

Completed

• Conditions: Infant Respiratory Distress Syndrome
• Interventions: Procedure: Premedication of intubation

• Registration Number: NCT03359993
• Lead Sponsor: Hôpital NOVO

Brief Summary

The investigators describe a simple and efficient method to give a premedication in the delivery room, using the umbilical vein, directly punctured through Wharton's jelly.

Detailed Description

The umbilical vein is punctured to inject drugs efficiently. The access is simple, the umbilical vein is clearly visible, and a blood reflux can be found easily. The investigators used the same equipment required for a peripheral venous injection: 24 gauge cannula, antisepsis, compress, and a syringe with the prepared anesthetic drugs. The investigators report 5 cases of intubations in the delivery room using this method to administer the premedication.

Study Timeline

• Study Start: 2016-11-01
• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-12-02
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2021-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• All the patients were preterm neonates intubated in the delivery room for infant respiratory distress syndrome (IRDS).

Exclusion Criteria

• Refusal of legal owners

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm infants intubated	Premedication of intubation	All participants were preterm infants intubated in the delivery room for Infantile Respiratory Distress Syndrome (IRDS). The purpose of this research is to determine a premedication of intubation. This consists of describing a simple and effective method for premedication in the delivery room, using the umbilical vein, directly perforated through the Wharton jelly.

Primary Outcome Measures

Name	Time	Method
Conditions of intubation	Seven months	Classified from bad to excellent, depending on the neonates' residual tone, vocal chords mobility, and persistence of movements while inserting the tube.

Secondary Outcome Measures

Name	Time	Method
Duration of intubation	Seven months	The investigators measure the time in seconds between insertion of the tube and the end of fixation.

Trial Locations

Locations (1)

Centre Hospitalier René Dubos; 🇫🇷 Pontoise, France