Airway Evaluation by McGrath Videolaryngoscope

Anesthesia Clinical Trial

Official title:

Comparison of Cormack-Lehane Score in Sedation and Anesthesia Condition by McGrath Videolaryngoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824914
• Other study ID #: TJMZK20121231
• Status: Completed
• Phase: N/A
• First received: March 25, 2013
• Last updated: November 6, 2014
• Start date: April 2013
• Est. completion date: October 2013

Study information

• Verified date: November 2014
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Difficult tracheal intubation is a cause of severe patient damage and death. There is not a good method to predict it. The McGrath Series 5 video laryngoscope can improve visualization of the glottic structures one to two grades. Moreover unlike a classical laryngoscope with a Macintosh blade, the McGrath provides a view of the glottis without requiring alignment of the oral, pharyngeal and laryngeal axes. In this study, the investigators will use it to compare the Cormack-Lehane score in sedation and anesthesia condition. It helps to know the role of videolaryngoscope in predicting difficult intubation.

Description:

• The enrolled patients were given a bolus of sufentanil 0.3-0.5μg/kg to achieve Ramsay sedation score 2-3. The Cormack-Lehane score in sedation was evaluated by McGrath videolaryngoscope.

• Then the patients were induced with propofol. A bolus of rocuronium was given to facilitate intubation. The Cormack-Lehane score in anesthesia was recorded when intubated by McGrath videolaryngoscope.

• BMI, mouth opening, thyromental distance, intubation duration and ramsay sedation score were also recorded.

• To compare the Cormack-Lehane score in sedate and anesthesia condition

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients scheduled for general surgery under general anesthesia

• ASA classification 1-3

Exclusion Criteria:

• emergent operation, aspiration risk

• a history of difficult airway

• expected difficult airway

• incooperative patients with mental diseases, hearing disorders

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• McGrath Videolaryngoscope
A kind of portable videolaryngoscopes, produced by Aircraft Medical. It has been used for difficult airway.

Locations

Country	Name	City	State
China	Tongji Hospital, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BMI		One day before operation	Yes
Other	Thyromental distance	measuring with a ruler	One day before operation	Yes
Other	Mallampati classification	4 degrades	One day before operation	Yes
Other	Mouth opening	measuring with a ruler	One day before operation	Yes
Primary	Cormack-Lehane score in sedation condition	Based on the Modified Cormack-Lehane classification. 5 degrades. 1-5	5 minutes after administration of sufentanil	Yes
Primary	Cormack-lehane score in anesthesia condition	Based on the Modified Cormack-Lehane classification. 5 degrades. 1-5	1 minute after administration of rocuronium	Yes
Secondary	Duration of intubation	The duration of intubation is defined as the time from inserting videolaryngoscope, intubating a tube, to withdrawing videolaryngoscope using a stopwatch.	At intubation	No
Secondary	Sedation score	by Ramsay sedation score 1-6. The higher score, the deeper sedation	5 minutes after administraion of sufentanil	Yes