Neutral Position Facilitates Orotracheal Intubation With Videolaryngoscopes

NCT ID: NCT04858906

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2024-12-31

Brief Summary

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With the advent and more widespread use of video-assisted laryngoscopy (VL), the incidence of difficult intubation has decreased. However, the optimal position for endotracheal intubation facilitated by VL is not yet determined. The objective of this study is to evaluate the effects of different patient positioning (neutral position versus sniffing position) on the glottic view and intubation time during orotracheal intubation facilitated by two video-assisted laryngoscopes (McGrath laryngoscope and C-MAC D-blade laryngoscope). A total of 252 patients who required orotracheal intubation for elective surgery were included in the study. Primary outcomes include airway difficulty score(ADS), intubation difficulty scale (IDS), the percentage of glottic opening (POGO) and intubation time. By the indexes above and crossover analysis, the study aimed to prove the ideal position for VL.

Detailed Description

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Endotracheal tube general anesthesia (ETGA) is required for a variety of surgeries. Traditionally, the patient is placed in a sniffing position to facilitate endotracheal intubation with a direct laryngoscope. Increased attempts in intubation or intubation failed may be encountered during direct laryngoscope, leading to hypoxemia or neurological sequelae. Injure to the teeth, gingiva or lips is also sometimes unavoidable. With the advent and more widespread use of video-assisted laryngoscopy (VL), the incidence of difficult intubation has decreased.

However, the optimal position for endotracheal intubation facilitated by VL is not yet determined. A previous study suggested that better glottic view is achieved when placing the patient in a neutral position than the sniffing position during orotracheal intubation by fiberoptic bronchoscopy. The objective of this study is to evaluate the effects of different patient positioning (neutral position versus sniffing position) on the glottic view and intubation time during orotracheal intubation facilitated by two video-assisted laryngoscopes (McGrath laryngoscope and C-MAC D-blade laryngoscope).

A total of 252 American Society of Anesthesiologists I-II patients, in the age above 20 years, who required orotracheal intubation for elective surgery were included in the study. Patients received nasotracheal intubation, awake tracheal intubation, emergency surgery, required rapid-sequence intubation (RSI), those in pregnancy, with possible difficult intubation(with oropharyngeal pathology, limited neck mobility, previous head and neck surgical history), anticipated difficult intubation assessed by preoperative Airway Difficult Score(ADS)(≥ 7), with allergy history of common anesthetics agents or any underlying comorbidities which refrain them from receiving common anesthetic agents were excluded.

The types of VL and the orders of position were randomly allocated by computer and the study take place in the operation room. Primary outcomes include airway difficulty (evaluated by ADS), ease of intubation (evaluated by intubation difficulty scale \[IDS\], the percentage of glottic opening \[POGO\]) and intubation time. By the indexes above and crossover analysis, the study aimed to prove the ideal position for VL, improve the efficiency of intubation and decrease the rate of difficult intubation by VL in the future.

Conditions

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Orotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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from neutral to sniffing position

The patients in this group will be assessed firstly in the neutral position then subsequently in the sniffing position.

Group Type ACTIVE_COMPARATOR

McGrath laryngoscope

Intervention Type DEVICE

The patients in this group will be evaluated and intubated with McGrath laryngoscope (angulated videolaryngoscope).

C-MAC D-blade laryngoscope

Intervention Type DEVICE

The patients in this group will be evaluated and intubated with C-MAC D-blade laryngoscope (hyperangulated videolaryngoscope).

from sniffing position to neutral position

The patients in this group will be assessed firstly in the sniffing position then subsequently in the neutral position.

Group Type ACTIVE_COMPARATOR

McGrath laryngoscope

Intervention Type DEVICE

The patients in this group will be evaluated and intubated with McGrath laryngoscope (angulated videolaryngoscope).

C-MAC D-blade laryngoscope

Intervention Type DEVICE

The patients in this group will be evaluated and intubated with C-MAC D-blade laryngoscope (hyperangulated videolaryngoscope).

Interventions

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McGrath laryngoscope

The patients in this group will be evaluated and intubated with McGrath laryngoscope (angulated videolaryngoscope).

Intervention Type DEVICE

C-MAC D-blade laryngoscope

The patients in this group will be evaluated and intubated with C-MAC D-blade laryngoscope (hyperangulated videolaryngoscope).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age above 20 years
* Anesthesiologists I-II
* who required orotracheal intubation for elective surgery

Exclusion Criteria

* nasotracheal intubation
* awake tracheal intubation
* emergency surgery
* required rapid-sequence intubation (RSI)
* those in pregnancy
* with possible difficult intubation(with oropharyngeal pathology, limited neck mobility, previous head and neck surgical history)
* anticipated difficult intubation assessed by preoperative Airway Difficult Score (≥ 7)
* with allergy history of common anesthetics agents
* any underlying comorbidities which refrain them from receiving common anesthetic agents
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mackay Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chien-Chung,Huang

Principal Investigator,Attending physician of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chien-Chung Huang, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

References

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Greenland KB, Edwards MJ, Hutton NJ, Challis VJ, Irwin MG, Sleigh JW. Changes in airway configuration with different head and neck positions using magnetic resonance imaging of normal airways: a new concept with possible clinical applications. Br J Anaesth. 2010 Nov;105(5):683-90. doi: 10.1093/bja/aeq239. Epub 2010 Sep 15.

Reference Type BACKGROUND
PMID: 20846964 (View on PubMed)

Park S, Lee HG, Choi JI, Lee S, Jang EA, Bae HB, Rhee J, Yang HC, Jeong S. Comparison of vocal cord view between neutral and sniffing position during orotracheal intubation using fiberoptic bronchoscope: a prospective, randomized cross over study. BMC Anesthesiol. 2019 Jan 5;19(1):3. doi: 10.1186/s12871-018-0671-9.

Reference Type BACKGROUND
PMID: 30611215 (View on PubMed)

Kang R, Jeong JS, Ko JS, Ahn J, Gwak MS, Choi SJ, Hwang JY, Hahm TS. Neutral Position Facilitates Nasotracheal Intubation with a GlideScope Video Laryngoscope: A Randomized Controlled Trial. J Clin Med. 2020 Mar 2;9(3):671. doi: 10.3390/jcm9030671.

Reference Type BACKGROUND
PMID: 32131521 (View on PubMed)

Other Identifiers

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20MMHIS438e

Identifier Type: -

Identifier Source: org_study_id

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