Umbilical Vein Needle Catheterization for Endotracheal Intubation.

Sponsor
Centre Hospitalier René Dubos (Other)
Overall Status
Completed
CT.gov ID
NCT03359993
Collaborator
(none)
5
1
34
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Premedication of intubation

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 Design

Study Type:
Observational
Actual Enrollment :
5 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Umbilical Vein Needle Catheterization for Endotracheal Intubation.
Actual Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Preterm infants intubated

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Duration of intubation [Seven months]

    The investigators measure the time in seconds between insertion of the tube and the end of fixation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 30 Minutes
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier René Dubos Pontoise France 95390

Sponsors and Collaborators

  • Centre Hospitalier René Dubos

Investigators

  • Principal Investigator: Suzanne BORRHOMEE, Centre Hospitalier René Dubos

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier René Dubos
ClinicalTrials.gov Identifier:
NCT03359993
Other Study ID Numbers:
  • CHRD0417
First Posted:
Dec 2, 2017
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier René Dubos
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2022