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Clinical Trials/NCT02026882
NCT02026882
Completed
Not Applicable

Supreme Laryngeal Mask Use in Urgent Caesarean Section

QuanZhou Women and Children's Hospital1 site in 1 country584 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Morbidity
Sponsor
QuanZhou Women and Children's Hospital
Enrollment
584
Locations
1
Primary Endpoint
First attempt insertion success rate
Status
Completed
Last Updated
5 years ago

Overview

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.

Detailed Description

Investigators propose a prospective cohort study to study the first attempt insertion success rate of supreme LMA in general anaesthesia for urgent caesarean section.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
May 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
QuanZhou Women and Children's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Wei Yu Yao

Dr

QuanZhou Women and Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

First attempt insertion success rate

Time Frame: 1 hour

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

Secondary Outcomes

  • Regurgitation(1 hour)
  • Aspiration(1 hour)
  • Time to effective airway placement(1 hour)
  • blood on SLMA on removal(1 hour)
  • Sore throat(1 hour)
  • Seal pressure(1 hour)
  • Gastric aspirate(1 hour)
  • Neonatal outcomes(1 hour)

Study Sites (1)

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