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Supreme LMA and Endotracheal Intubation Use in Caesarean Section

NCT01858467 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 920

Last updated 2018-05-07

No results posted yet for this study

Summary

The LMA Supreme (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 Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. The current practice is to use endotracheal intubation with rapid sequence induction in general anaesthesia for Caesarean section.

The primary study hypothesis is the first attempt insertion success rate of SLMA and endotracheal intubation are equivalent with a difference of less than 3%.

Conditions

  • Complications; Cesarean Section

Interventions

DEVICE

Endotracheal intubation

Portex endotracheal tube 6.5mm or 7.0mm internal diameter

DEVICE

Supreme Laryngeal Mask Airway

Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    collaborator OTHER_GOV

  • Wei Yu Yao

    lead OTHER

Principal Investigators

  • Shi Y Li, MD · Quanzhou Women's and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-07-31
Completion
2014-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01858467 on ClinicalTrials.gov