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

NCT ID: NCT04483895

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2020-12-21

Brief Summary

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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.

Detailed Description

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Conditions

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Endotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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The OHL method

the ETT insertion depth was estimated according to the OHL method.

Group Type ACTIVE_COMPARATOR

Endotracheal tube insertion

Intervention Type PROCEDURE

ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method

The 7-8-9 method

the ETT insertion depth was estimated according to the 7-8-9 method.

Group Type ACTIVE_COMPARATOR

Endotracheal tube insertion

Intervention Type PROCEDURE

ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method

Interventions

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Endotracheal tube insertion

ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method

Intervention Type PROCEDURE

Eligibility Criteria

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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

\- 1. Major upper or lower airway anomalies. 2. Infants with craniofacial, vertebral anomalies. 3. Significant congenital anomalies including cardiac, abdominal or respiratory.

4\. Neonates those whose parents declined consent were excluded from the study.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Dina Mohamed Mohamed Shinkar

Assistant professor of pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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medicine -Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Dina Mohamed, M.D.

Role: primary

+1112636097

Other Identifiers

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Maha Abdel-Raouf master thesis

Identifier Type: -

Identifier Source: org_study_id

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