NCT02026882

Brief Summary

The Supreme Laryngeal Mask Airway (SLMA) is a single use supraglottic device that provides a good seal for positive pressure ventilation and good first attempt insertion rate of 98% in low risk patients undergoing elective Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. The primary study hypothesis is the first attempt insertion success rate of SLMA use in urgent Caesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
584

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

December 31, 2013

Last Update Submit

July 31, 2020

Conditions

Airway Morbidity

Keywords

Airway, Caesarean

Outcome Measures

Primary Outcomes (1)

  • First attempt insertion success rate

    An attempt is defined as insertion and withdrawal of the device from the patient's airway

    1 hour

Secondary Outcomes (8)

  • Time to effective airway placement

    1 hour

  • Aspiration

    1 hour

  • blood on SLMA on removal

    1 hour

  • Sore throat

    1 hour

  • Regurgitation

    1 hour

  • +3 more secondary outcomes

Study Arms (1)

Supreme Laryngeal Mask Airway

OTHER

Supreme Laryngeal Mask Airway with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.

Device: Supreme Laryngeal Mask Airway

Interventions

Supreme Laryngeal Mask AirwayDEVICE

Supreme Laryngeal Mask Airway. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.

Supreme Laryngeal Mask Airway

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 50 years old
  • American Society of Anesthesiology status 1 or 2
  • Weight 40 to 75kg
  • Normal airway assessment
  • Term pregnancy (36 weeks or more)
  • Urgent Caesarean Section

You may not qualify if:

  • Body mass index (35 or more)
  • Difficult airway (Mallampati 4 or abnormal airway assessment)
  • Gastrooesophageal reflux

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quanzhou Women's and Children's Hospital

Quanzhou, Fujian, 700, China

Location

Related Publications (3)

  • Lim MJ, Tan HS, Tan CW, Li SY, Yao WY, Yuan YJ, Sultana R, Sng BL. The effects of labor on airway outcomes with Supreme laryngeal mask in women undergoing cesarean delivery under general anesthesia: a cohort study. BMC Anesthesiol. 2020 Aug 26;20(1):213. doi: 10.1186/s12871-020-01132-5.

    PMID: 32847548DERIVED

  • Tan HS, Li SY, Yao WY, Yuan YJ, Sultana R, Han NR, Sia ATH, Sng BL. Association of Mallampati scoring on airway outcomes in women undergoing general anesthesia with Supreme laryngeal mask airway in cesarean section. BMC Anesthesiol. 2019 Jul 8;19(1):122. doi: 10.1186/s12871-019-0796-5.

    PMID: 31286890DERIVED

  • Li SY, Yao WY, Yuan YJ, Tay WS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Supreme laryngeal mask airway use in general Anesthesia for category 2 and 3 Cesarean delivery: a prospective cohort study. BMC Anesthesiol. 2017 Dec 19;17(1):169. doi: 10.1186/s12871-017-0460-x.

    PMID: 29258438DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 31, 2013

First Posted

January 3, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

August 3, 2020

Record last verified: 2020-07

Locations

CN(1)