Comparing the "sniffing Position" , "Simple Head Extension" and "Neutral Position"

Randomized Study Comparing the "sniffing Position" , "Simple Head Extension" and "Neutral Position" for Awake Orotracheal Intubation With Fiberoptic in Anticipate Difficult Airway Patients

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.

Study Overview

• Status: Completed
• Conditions: Therapeutic Procedural Complication
• Intervention / Treatment: Device: sniffing Position(place a 7-cm cushion under head ); Device: Simple Head Extension(without cushion)

Detailed Description

The study included seventy-five patients with anticipated difficult airways. The sniffing position was obtained by placement of a 7-cm cushion under the head of the patient. The extension head position was obtained by by placement of a 7-cm cushion under the shoulder.

The head position was randomized as follows: neutral position group (NP group), sniffing position group (SP group) or extension position group (EP group) Randomization was performed by placing index cards with the letter NP or SP or EP into75 sealed envelopes , which were then placed in random order. At the time of a patient's enrollment, the next available envelope was placed with the patient's chart. At the time of intubation, the envelope was opened and the sequence was thus determined.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • 中国

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Exclusion criteria included age younger than 18 yr
• ASA class IV or V
• Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: sniffing Position; 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 ); 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
EXPERIMENTAL: Simple Head Extension; 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); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Occurrence of throat pain measured by VAS	one day Postoperative

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2017
• Primary Completion (ACTUAL): June 22, 2020
• Study Completion (ACTUAL): August 30, 2020

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 7, 2016
• First Posted (ESTIMATE): June 8, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: neutral position; Simple Head Extension; Sniffing Position
• Other Study ID Numbers: 9958

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No