NCT05331287

Brief Summary

The simple head extension is recommended for optimization of glottic visualization during Nasotracheal intubation via fiberoptic bronchoscope (FOB) . However, no study confirmed its superiority over"snifing position" and "Neutral Position". In a prospective, randomized study, the authors compared the snifing position , simple head extension and "Neutral Position" in Nasotracheal intubation via fiberoptic bronchoscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 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

March 27, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

April 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

March 27, 2022

Last Update Submit

February 14, 2023

Conditions

Keywords

Snifing PositionSimple Head Extensionneutral positionNasotracheal intubation

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 (3)

snifing Position

EXPERIMENTAL

Nasotracheal intubation via fiberoptic bronchoscope under snifing position.The snifing position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into Nasal 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.

Other: Head position

neutral position

EXPERIMENTAL

Nasotracheal intubation via fiberoptic bronchoscope under snifing position.The Head Extension was obtained by the occiput of the patient close to the operating table. When the FOB was inserted into Nasal 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.

Other: Head position

Head Extension

EXPERIMENTAL

Nasotracheal intubation via fiberoptic bronchoscope under snifing position.The extension position with a 7-cm pillow underneath the shoulder and the occiput close to the operating table. When the FOB was inserted into Nasal 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.

Other: Head position

Interventions

Influence of different head position on nasal endotracheal intubation

Head Extensionneutral positionsnifing Position

Eligibility Criteria

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

You may qualify if:

  • 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)

The first hospital of Qinhuangdao

Qinhuangdao, Hebei, 066000, China

Location

MeSH Terms

Interventions

Head-Down Tilt

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

March 27, 2022

First Posted

April 15, 2022

Study Start

April 20, 2022

Primary Completion

June 30, 2022

Study Completion

August 30, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations