NCT04483895

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

July 21, 2020

Last Update Submit

July 21, 2020

Conditions

Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

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

    28 days

Secondary Outcomes (1)

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

    28 days

Study Arms (2)

The OHL method

ACTIVE COMPARATOR

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

Procedure: Endotracheal tube insertion

The 7-8-9 method

ACTIVE COMPARATOR

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

Procedure: Endotracheal tube insertion

Interventions

Endotracheal tube insertionPROCEDURE

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

The 7-8-9 methodThe OHL method

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Full term and preterm neonates who were admitted to NICU and needing endotracheal intubation for invasive mechanical ventilation or administration of surfactant.

You may not qualify if:

  • \- 1. Major upper or lower airway anomalies. 2. Infants with craniofacial, vertebral anomalies. 3. Significant congenital anomalies including cardiac, abdominal or respiratory.
  • \. Neonates those whose parents declined consent were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

medicine -Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of pediatrics

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 23, 2020

Study Start

November 15, 2019

Primary Completion

December 21, 2020

Study Completion

December 21, 2020

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

EG(1)