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

Not Applicable

• Conditions: Endotracheal Intubation

• Registration Number: NCT04483895
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-15
• Status Verified: 2020-07
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23
• Primary Completion: 2020-12-21
• Study Completion: 2020-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the proportion of ETTs in abnormal position for each of both insertion depth prediction methods.	28 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

medicine -Ain Shams University; 🇪🇬 Cairo, Egypt