NCT02792855

Brief Summary

The simple head extension is recommended for optimization of glottic visualization during awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date has confirmed its superiority over "sniffing position" . In a prospective, randomized study, the authors compared the sniffing position , simple head extension and "Neutral Position" in awake orotracheal Intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

May 31, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

April 11, 2022

Status Verified

November 1, 2020

Enrollment Period

3 years

First QC Date

May 31, 2016

Last Update Submit

April 1, 2022

Conditions

Therapeutic Procedural Complication

Keywords

Sniffing PositionSimple Head Extensionneutral position

Outcome Measures

Primary Outcomes (1)

  • Intubation Time

    The primary endpoints were the time to view the vocal cords (TVC) which was taken when the operator indicated verbally that he view the vocal cords and the time to successful tracheal intubation (TSI). TSI was defined as the time taken from insertion of the FOB between the teeth until the appearance of a capnograhy curve.

    Ten minutes

Secondary Outcomes (1)

  • Occurrence of throat pain measured by VAS

    one day Postoperative

Study Arms (2)

sniffing Position

EXPERIMENTAL

Awake fiberoptic bronchoscope(FOB) orotracheal under sniffing position.The sniffing position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB

Device: sniffing Position(place a 7-cm cushion under head )

Simple Head Extension

EXPERIMENTAL

Awake fiberoptic bronchoscope(FOB) orotracheal under Head Extension position.The Head Extension position was obtained by simple head extension.When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB

Device: Simple Head Extension(without cushion)

Interventions

sniffing Position(place a 7-cm cushion under head )DEVICE

Awake fiberoptic bronchoscope(FOB) orotracheal under sniffing position.The sniffing position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB

sniffing Position
Simple Head Extension(without cushion)DEVICE

Awake fiberoptic bronchoscope(FOB) orotracheal under Head Extension position.The Head Extension position was obtained by simple head extension.When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB

Simple Head Extension

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI greater than 30 kg/m2
  • ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.

You may not qualify if:

  • ASA class IV or V
  • Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

中国

Qinhuangdao, Hebei, 066000, China

Location

Related Publications (1)

  • Liu Z, Zhao L, Ma Z, Liu M, Qi X, Jia Q, Liang S, Yang X. Effects of head positions on awake fiberoptic bronchoscope oral intubation: a randomized controlled trial. BMC Anesthesiol. 2021 Jun 23;21(1):176. doi: 10.1186/s12871-021-01397-4.

    PMID: 34162330DERIVED

Study Officials

  • Ximing Qi

    The First Hospital of Qinhuangdao

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 8, 2016

Study Start

June 15, 2017

Primary Completion

June 22, 2020

Study Completion

August 30, 2020

Last Updated

April 11, 2022

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Locations

CN(1)