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

Therapeutic Procedural Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792855
• Other study ID #: 9958
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: November 2020
• Source: The First Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 30, 2020
• Est. primary completion date: June 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Therapeutic Procedural Complication

Intervention

Device:
• snif?ng Position(place a 7-cm cushion under head )
Awake fiberoptic bronchoscope(FOB) orotracheal under snif?ng position.The snif?ng 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)
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

Locations

Country	Name	City	State
China	??	Qinhuangdao	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Occurrence of throat pain measured by VAS		one day Postoperative