Clinical trial NCT04858906: Neutral Position Facilitates Orotracheal Intubation With Videolaryngoscopes
Official title: Neutral Position Facilitates Orotracheal Intubation With Videolaryngoscopes: A Comparing Angulated (McGrath) and Hyperangulated (C-MAC With D-blade) Videolaryngoscopes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Orotracheal Intubation
Keywords: orotracheal intubation
neutral position
sniffing position
video-assisted laryngoscopes
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: airway difficult score (ADS)
timeFrame: Airway difficult score (ADS) is assessed before induction and it take about 3 minutes.
measure: intubation difficulty scale (IDS)
timeFrame: intubation difficulty scale (IDS) is assessed during intubation and the time it take depend on the difficulty of the case.
measure: percentage of glottic opening (POGO)
timeFrame: Percentage of glottic opening (POGO) is evaluated by another anesthesiologist up to 24 hours after intubation ,and it take about 1 minutes.
measure: intubation time
timeFrame: Intubation time is assessed during intubation and the time it take depend on the difficulty of the case.
Secondary outcomes:
measure: complications
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Mackay Memorial Hospital
name: Chien-Chung Huang, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.