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

Not Applicable

Completed

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

• Registration Number: NCT02792855
• Lead Sponsor: The First Hospital of Qinhuangdao

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-08
• Study Start: 2017-06-15
• Primary Completion: 2020-06-22
• Study Completion: 2020-08-30
• Status Verified: 2020-11
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Simple Head Extension	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
sniffing Position	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

Primary Outcome Measures

Name	Time	Method
Intubation Time	Ten minutes	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.

Secondary Outcome Measures

Name	Time	Method
Occurrence of throat pain measured by VAS	one day Postoperative

Trial Locations

Locations (1)

中国; 🇨🇳 Qinhuangdao, Hebei, China