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Clinical Trials/NCT04483895
NCT04483895
Unknown
Not Applicable

Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates

Ain Shams University1 site in 1 country120 target enrollmentNovember 15, 2019
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ConditionsEndotracheal Intubation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endotracheal Intubation
Sponsor
Ain Shams University
Enrollment
120
Locations
1
Primary Endpoint
the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This study was conducted on neonates needing intubation; Group A,: the ETT insertion depth was estimated according to the OHL method. Group B,: the ETT insertion depth was estimated according to the 7-8-9 method.

Registry
clinicaltrials.gov
Start Date
November 15, 2019
End Date
December 21, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dina Mohamed Mohamed Shinkar

Assistant professor of pediatrics

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • •• Full term and preterm neonates who were admitted to NICU and needing endotracheal intubation for invasive mechanical ventilation or administration of surfactant.
  • •Delivery room intubations were not included as infants are not routinely weighed prior to resuscitation at our hospital. However, infants intubated in the delivery room who were subsequently intubated in the NICU were eligible for inclusion in our study.

Exclusion Criteria

  • •Major upper or lower airway anomalies.
  • •Infants with craniofacial, vertebral anomalies.
  • •Significant congenital anomalies including cardiac, abdominal or respiratory.
  • •Neonates those whose parents declined consent were excluded from the study.

Outcomes

Primary Outcomes

the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.

Time Frame: 28 days

Secondary Outcomes

  • the occurrence of pulmonary air leaks during the first 24 hours after intubation, accidental extubation and duration of ventilation.(28 days)

Study Sites (1)

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