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Completed

NCT Number: NCT02792855

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

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.

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Key information

Conditions

Therapeutic Procedural Complication

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

中国

Qinhuangdao, Hebei, 066000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sniffing Position(place a 7-cm cushion under head )

Device

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

Simple Head Extension(without cushion)

Device

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

Primary outcomes

  1. Intubation Time

    Time frame: 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 outcomes

  1. Occurrence of throat pain measured by VAS

    Time frame: one day Postoperative

Sponsors and collaborators

Lead sponsor

The First Hospital of Qinhuangdao

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2016
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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