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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05331287
Other study ID # 5866
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2022
Est. completion date August 30, 2022

Study information

Verified date February 2023
Source The First Hospital of Qinhuangdao
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Therapeutic Procedural Complication

Intervention

Other:
Head position
Influence of different head position on nasal endotracheal intubation

Locations

Country Name City State
China The first hospital of Qinhuangdao 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]
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