Skip to main content
OpenTrials
Completed

NCT Number: NCT02026882

Supreme LMA Use in Urgent Caesarean Section

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Airway Morbidity

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Quanzhou Women's and Children's Hospital

Quanzhou, Fujian, 700, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supreme Laryngeal Mask Airway

Device

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

Primary outcomes

  1. 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

  1. Time to effective airway placement

    Time frame: 1 hour

    Interval from when the device was picked up until appearance of the first end-tidal carbon dioxide waveform

  2. Aspiration

    Time frame: 1 hour

    Signs of aspiration as evidenced by perioperative hypoxaemia, wheezing or crepitations upon auscultation of lungs or postoperative dyspnoea with chest x ray signs of aspiration

  3. blood on SLMA on removal

    Time frame: 1 hour

    inspection for presence of blood upon removal of SLMA

  4. Sore throat

    Time frame: 1 hour

    Sore throat present in recovery room

  5. Regurgitation

    Time frame: 1 hour

    Gastric contents identified in the mouth with pH less than 4

  6. Seal pressure

    Time frame: 1 hour

    Recorded by closing the adjustable pressure limiting valve and insufflating the closed breathing system with 3L/min fresh gas flow. The peak circuit airway pressure achieved will be recorded.

  7. Gastric aspirate

    Time frame: 1 hour

    Volume of gastric aspirate using gastric tube and pH of gastric aspirate using litmus paper

  8. Neonatal outcomes

    Time frame: 1 hour

    Neonatal birthweight. APGAR score. Umbilical venous cord pH

Sponsors and collaborators

Lead sponsor

QuanZhou Women and Children's Hospital

Other

Collaborators

  • KK Women's and Children's Hospital

Registry information

Official study title

Supreme Laryngeal Mask Use in Urgent Caesarean Section

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 3, 2014
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.