- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05331287
Comparing the "Snifing Position" , "Simple Head Extension" and "Neutral Position"
February 14, 2023 updated by: The First Hospital of Qinhuangdao
First Hospital of Qinhuangdao,Hebei Province, China
The simple head extension is recommended for optimization of glottic visualization during Nasotracheal intubation via fiberoptic bronchoscope (FOB) .
However, no study confirmed its superiority over"snifing position" and "Neutral Position".
In a prospective, randomized study, the authors compared the snifing position , simple head extension and "Neutral Position" in Nasotracheal intubation via fiberoptic bronchoscope.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study included ninety patients with anticipated difficult airways.
The snifing position was obtained by placement of a 7-cm cushion under the head of the patient; the extension head position was obtained by placement of a 7-cm cushion under the shoulder; the neutral position with the occiput close to the operating table.
The head position was randomized as follows: neutral position group (NP group), sniffing position group (SP group) or extension position group (EP group).
Randomization (1:1:1) was based on the codes generated by Excel software, which were kept in sequentially numbered opaque envelopes until the began of study.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hebei
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Qinhuangdao, Hebei, China, 066000
- The First Hospital of Qinhuangdao
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.
Exclusion Criteria:
• ASA class IV or V
- Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: snifing Position
Nasotracheal intubation via fiberoptic bronchoscope under snifing position.The snifing position was obtained by placement of a 7-cm cushion under the head of the patient.
When the FOB was inserted into Nasal 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.
|
Influence of different head position on nasal endotracheal intubation
|
Experimental: neutral position
Nasotracheal intubation via fiberoptic bronchoscope under snifing position.The Head Extension was obtained by the occiput of the patient close to the operating table.
When the FOB was inserted into Nasal 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.
|
Influence of different head position on nasal endotracheal intubation
|
Experimental: Head Extension
Nasotracheal intubation via fiberoptic bronchoscope under snifing position.The extension position with a 7-cm pillow underneath the shoulder and the occiput close to the operating table.
When the FOB was inserted into Nasal 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.
|
Influence of different head position on nasal endotracheal intubation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Ten minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of throat pain measured by VAS
Time Frame: one day Postoperative]
|
one day Postoperative]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2022
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
August 30, 2022
Study Registration Dates
First Submitted
March 27, 2022
First Submitted That Met QC Criteria
April 12, 2022
First Posted (Actual)
April 15, 2022
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 14, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 5866
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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