NCT02993692

Brief Summary

The aim of study was to compare the hemodynamic responses and adverse events associated with nasotracheal intubation (NTI) using a fiberoptic bronchoscope (FOB) and a direct laryngoscope (DLS) in children undergoing general anesthesia for outpatient dental surgery. Eighty children (aged 5-15 years) were scheduled to undergo outpatient dental surgery under general anesthesia and who required nasotracheal intubation were included.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1 month

First QC Date

December 1, 2016

Last Update Submit

February 22, 2018

Conditions

Nasotracheal Intubation

Keywords

direct laryngoscopyfiberopitc bronchoscopynasotracheal intubation

Outcome Measures

Primary Outcomes (3)

  • Systolic blood pressure

    From Begining of Anesthesia induction to 5th minutes of intubation

  • Heart rate

    From Begining of Anesthesia induction to 5th minutes of intubation

  • Adverse events

    within the first 24 hour after surgery

Study Arms (2)

fiberoptic bronchoscopy

OTHER

I want to see the difference between the two group about hemodynamic and intraoculer pressure responses about fiberoptic bronchoscopy.

Device: Direct laryngoscopy and fiberoptic bronchoscopy

direct laryngoscopy

OTHER

I want to see the difference between the two group about hemodynamic and intraoculer pressure responses about direct laryngoscopy.

Device: Direct laryngoscopy and fiberoptic bronchoscopy

Interventions

Direct laryngoscopy and fiberoptic bronchoscopyDEVICE

These devices is used in endotracheal intubation and tonopen for measuring of intraoculer pressure. I want to see whcih is better.

Also known as: tonopen
direct laryngoscopyfiberoptic bronchoscopy

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA physical status of I-II, had a Mallampati Score of 1-2, were aged 5-15 years, were scheduled to undergo outpatient dental surgery under general anesthesia

You may not qualify if:

  • The patient's refusal for study consent, active upper respiratory infection, airway abnormalities, nasal mass or nasal injury, bleeding disorders, allergies to anesthetics, uncontrolled hypertension, morbid obesity, hepatic or renal failure, cardiovascular diseases, a history of nasopharyngeal surgery and those who were difficult to intubate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 15, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2017

Study Completion

April 4, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share