Umbilical Vein Needle Catheterization for Endotracheal Intubation. (Intubation)

January 25, 2022 updated by: Centre Hospitalier René Dubos
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pontoise, France, 95390
        • Centre Hospitalier Rene Dubos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 minutes (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conditions of intubation
Time Frame: Seven months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of intubation
Time Frame: Seven months
The investigators measure the time in seconds between insertion of the tube and the end of fixation.
Seven months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier René Dubos

Investigators

  • Principal Investigator: Suzanne BORRHOMEE, Centre Hospitalier Rene Dubos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRD0417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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