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

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.

Study Overview

• Status: Unknown
• Conditions: Endotracheal Intubation
• Intervention / Treatment: Procedure: Endotracheal tube insertion

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • medicine -Ain Shams University
    • Contact: Dina Mohamed, M.D.; Phone Number: +1112636097; Email: drdodi28@gmail.com
    • Principal Investigator: Dina Shinkar, M.D.
    • Principal Investigator: Abeer El-Sakka, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The OHL method; the ETT insertion depth was estimated according to the OHL method.	Procedure: Endotracheal tube insertion; ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method
Active Comparator: The 7-8-9 method; the ETT insertion depth was estimated according to the 7-8-9 method.	Procedure: Endotracheal tube insertion; ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
the occurrence of pulmonary air leaks during the first 24 hours after intubation, accidental extubation and duration of ventilation.	28 days

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Anticipated): December 21, 2020
• Study Completion (Anticipated): December 21, 2020

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Maha Abdel-Raouf master thesis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No