Neutral Position Facilitates Orotracheal Intubation With Videolaryngoscopes

NCT04858906 | Withdrawn

• 1 other identifier: 20MMHIS438e
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Orotracheal Intubation

Keywords

orotracheal intubation; neutral position; sniffing position; video-assisted laryngoscopes

Outcome Measures

Primary Outcomes (4)

• airway difficult score (ADS)

  Airway difficult score (ADS) represents the airway difficulty and it includes thyro-mental distance, Mallampati score, mouth opening, neck mobility and upper incisions. Each element will be scored from 1 to 3 points accordingly. The higher the scores are, the more difficult the airway could be. The minimum value and the maximum value of the airway difficult score (ADS) are 5 and 15 respectively. The definition of possible difficult airway is when the airway difficult score (ADS) score is more than 7 points.

  Airway difficult score (ADS) is assessed before induction and it take about 3 minutes.

• intubation difficulty scale (IDS)

  Intubation difficulty scale (IDS) represents ease of intubation and it includes times of intubation attempts, numbers of operators, grade of Modified Cormack-Lehane classification, lifting force, laryngeal pressure and vocal cord mobility. Intubation attempts, operators and grade of Modified Cormack-Lehane classification more than one will be scored directly to the numbers accordingly. The other elements will be scored from 0 to 1 point. The higher the scores are, the more difficult the intubation could be. The minimum value of the IDS is 0 and there is no limit of the maximum value. The definition of difficult intubation is when the intubation difficulty scale (IDS) score is more than 6 points.

  intubation difficulty scale (IDS) is assessed during intubation and the time it take depend on the difficulty of the case.

• percentage of glottic opening (POGO)

  Both the glottic views in first position and in second position are evaluated as percentage of glottic opening (POGO) score, ranging from 0 to 100%. The glottic views will be recorded as digital image and be evaluated by another anesthesiologist subsequently.

  Percentage of glottic opening (POGO) is evaluated by another anesthesiologist up to 24 hours after intubation ,and it take about 1 minutes.

• intubation time

  Time from when the patient's mouth is opened to the time when intubation is completed and the EtCO2 is detected by the monitor will be recorded.

  Intubation time is assessed during intubation and the time it take depend on the difficulty of the case.

Secondary Outcomes (1)

• complications

  Tissue injury, sore throat and hoarseness are evaluated in the postoperative period (the day after the surgery). Desaturation or not is assessed during the procedure.

Study Arms (2)

from neutral to sniffing position

ACTIVE COMPARATOR

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

Device: McGrath laryngoscope; Device: C-MAC D-blade laryngoscope

from sniffing position to neutral position

ACTIVE COMPARATOR

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

Device: McGrath laryngoscope; Device: C-MAC D-blade laryngoscope

Interventions

McGrath laryngoscope DEVICE

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

from neutral to sniffing position; from sniffing position to neutral position

C-MAC D-blade laryngoscope DEVICE

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

from neutral to sniffing position; from sniffing position to neutral position

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Related Publications (3)

• 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.

  PMID: 20846964 BACKGROUND

• 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.

  PMID: 30611215 BACKGROUND

• 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.

  PMID: 32131521 BACKGROUND

Study Officials

• Chien-Chung Huang, Bachelor

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,Attending physician of anesthesiology

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 26, 2021
• Study Start: May 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: December 31, 2024
• Last Updated: August 31, 2021

Record last verified: 2021-08