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

Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483895
• Other study ID #: Maha Abdel-Raouf master thesis
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: December 21, 2020

Study information

• Verified date: July 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

Procedure:
• Endotracheal tube insertion
ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method

Locations

Country	Name	City	State
Egypt	medicine -Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.		28 days
Secondary	the occurrence of pulmonary air leaks during the first 24 hours after intubation, accidental extubation and duration of ventilation.		28 days