NCT02732613

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

5 months

First QC Date

March 28, 2016

Last Update Submit

April 7, 2016

Conditions

Keywords

Laryngeal Mask AirwayBody weightComplication

Outcome Measures

Primary Outcomes (1)

  • The success rate of Laryngeal Mask Airway first insertion

    Six months

Study Arms (2)

Actual weight Group

EXPERIMENTAL

Patients in Actual weight Group: The selection of Laryngeal Mask Airway classic will be based on actual body weight, followed the recommendations of manufacturer (size 3 for weight \< 50 kg, size 4 for weight 50-70 kg, and size 5 for weight \> 70 kg ).

Device: Laryngeal Mask Airway

Ideal weight Group

EXPERIMENTAL

Patients in Ideal weight Group: The selection of Laryngeal Mask Airway classic will be based on ideal body weight, followed the recommendations of manufacturer ( size 3 for weight \< 50 kg, size 4 for weight 50-70 kg, and size 5 for weight \> 70 kg ).

Device: Laryngeal Mask Airway

Interventions

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.

Actual weight GroupIdeal weight Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult Patients undergo elective surgery of American Society of Anesthesiologists (ASA) physical status 1-2, aged from 18 to 60;
  • Patients' actual weight much less than ideal weight.

You may not qualify if:

  • Patients with gastroesophageal reflux disease;
  • Patients with predicted difficult airway;
  • Patients with preexisting airway diseases or significant upper airway infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Body Weight

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Xiqiang Huang, Bachelor

CONTACT

Yiquan Lin, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending doctor, Department of anesthesiology, Principal Investigator

Study Record Dates

First Submitted

March 28, 2016

First Posted

April 8, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04