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Umbilical Vein Needle Catheterization for Endotracheal Intubation. (Intubation)

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ClinicalTrials.gov Identifier: NCT03359993
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier René Dubos

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
Infant Respiratory Distress Syndrome 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.

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Study Type : Observational
Estimated Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Umbilical Vein Needle Catheterization for Endotracheal Intubation.
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Duration of intubation [ Time Frame: Seven months ]
    The investigators measure the time in seconds between insertion of the tube and the end of fixation.



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Ages Eligible for Study:   up to 30 Minutes   (Child)
Sexes 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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359993


Contacts
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Contact: Maryline DELATTRE +331.30.75.41.31 maryline.delattre@ght-novo.fr
Contact: Véronique DA COSTA +331.30.75.50.69 veronique.dacosta@ght-novo.fr

Locations
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France
Centre Hospitalier René Dubos Recruiting
Pontoise, France, 95390
Contact: Suzanne BORRHOME, Dr    01.30.75.42.70    suzanne.borrhomee@ght-novo.fr   
Contact: Véronique DA COSTA    +33 (0)1 30 75 50 69    veronique.dacosta@ght-novo.fr   
Sponsors and Collaborators
Centre Hospitalier René Dubos
Investigators
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Principal Investigator: Suzanne BORRHOMEE Centre Hospitalier René Dubos

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Responsible Party: Centre Hospitalier René Dubos
ClinicalTrials.gov Identifier: NCT03359993     History of Changes
Other Study ID Numbers: CHRD0417
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Endotracheal intubation
Neonatal premedication
Delivery room
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases