Umbilical Vein Needle Catheterization for Endotracheal Intubation.

Infant Respiratory Distress Syndrome Clinical Trial

— Intubation  

Official title:

Umbilical Vein Needle Catheterization for Endotracheal Intubation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359993
• Other study ID #: CHRD0417
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2021
• Source: Centre Hospitalier René Dubos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Gender: All
• Age group: N/A to 30 Minutes

Eligibility

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

Related Conditions & MeSH terms

• Infant Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• Premedication of intubation
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. We used the same equipment required for a peripheral venous injection: 24 gauge cannula, antisepsis, compress, and a syringe with the prepared anesthetic drugs. We report 5 cases of intubations in the delivery room using this method to administer the premedication.

Locations

Country	Name	City	State
France	Centre Hospitalier René Dubos	Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier René Dubos

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conditions of intubation	Classified from bad to excellent, depending on the neonates' residual tone, vocal chords mobility, and persistence of movements while inserting the tube.	Seven months
Secondary	Duration of intubation	The investigators measure the time in seconds between insertion of the tube and the end of fixation.	Seven months