Selection of Laryngeal Mask Airway in Patients With Slender Somatotype

Body Weight Clinical Trial

Official title:

Selection of Laryngeal Mask Airway When Actual Body Weight Much Less Than Ideal Body Weight in Adult Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02732613
• Other study ID #: ZSPH20160303
• Status: Not yet recruiting
• Phase: N/A
• First received: March 28, 2016
• Last updated: April 7, 2016
• Start date: April 2016
• Est. completion date: November 2016

Study information

• Verified date: April 2016
• Source: Zhongshan People's Hospital, Guangdong, China
• Contact: Xiqiang Huang, Bachelor
• Phone: +86-18923324188
• Email: 75303811[@]qq.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Zhongshan
• Study type: Interventional

Clinical Trial Summary

The size selection of Laryngeal Mask Airway classic is usually followed the manufacturer's recommendation based on the patient's ideal weight. But sometimes the patient is tall and slim, the actual weight is much less than the ideal weight. This phenomenon might affect the success rate of insertion. Previous studies had demonstrated that the selection of Laryngeal Mask Airway size based on ideal weight could improve the success rate of insertion; therefore, this study was designed to prove whether this conclusion also applies to the tall and thin patients.

Description:

One hundred and eighteen patients adult patients，actual body weight much less than ideal body weight will be assigned randomly to two groups (Actual weight Group or Ideal weight Group). Size selection was guided by the recommendations of manufacturer, patients will be based on the actual body weight in Actual weight Group while ideal body weight in Ideal weight Group.

The success rate of first attempt，number of adjustments, insertion time, ease of insertion, overall success rate, oropharyngeal leak pressure and fiberoptic view will be recorded and compared. The occurrences of respiratory complications such as sore throat, hoarseness, and dysphonia will be observed and recorded.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Adult Patients undergo elective surgery of American Society of Anesthesiologists (ASA) physical status 1-2, aged from 18 to 60;

2. Patients' actual weight much less than ideal weight.

Exclusion Criteria:

1. Patients with gastroesophageal reflux disease;

2. Patients with predicted difficult airway;

3. Patients with preexisting airway diseases or significant upper airway infection.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Body Weight
• Complication
• Size of Laryngeal Mask Airway
• Success Rate of First Attempt

Intervention

Device:
• Laryngeal Mask Airway
If there were any conflicts of the Laryngeal Mask Airway classic size selection in slim patients by the actual or ideal body weight, size selection will based on actual body weight in Actual weight Group while ideal body weight in Ideal weight Group.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
XiQiang Huang	Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of Laryngeal Mask Airway first insertion		Six months	No