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Completed

NCT Number: NCT01858467

Supreme LMA and Endotracheal Intubation Use in Caesarean Section

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%.

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Key information

Conditions

Complications; Cesarean Section

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

We propose a randomised controlled trial to study the first attempt insertion success rate of supreme LMA versus endotracheal intubation in general anaesthesia for elective 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
  • ASA 1 or 2
  • Fasted at least 6 hours
  • Weight 40 to 75kg
  • Normal airway assessment
  • Singleton term pregnancy (>36weeks)
  • Elective Caesarean section

Exclusion criteria

  • In labour
  • Body mass index >35
  • Difficult airway (Mallampati 4 or abnormal airway assessment)
  • Gastrooesophageal reflux disease

Treatment and study plan

Endotracheal intubation

Device

Portex endotracheal tube 6.5mm or 7.0mm internal diameter

Supreme Laryngeal Mask Airway

Device

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

Primary outcomes

  1. First attempt insertion success rate

    Time frame: 1 hour

    An attempt is defined as insertion and complete 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 wave form

  2. Aspiration

    Time frame: 1 hour

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

  3. blood on SLMA on removal

    Time frame: 1 hour

    inspection for presence of blood on Supreme Laryngeal Mask Airway on removal

  4. Sore Throat

    Time frame: 1 hour

    Sore throat present in the postanaesthesia care unit

  5. Patient satisfaction

    Time frame: 1 hour

    Patient satisfaction with whole anaesthetic experience at 24 hours postsurgery (0 to 100%)

  6. Regurgitation

    Time frame: 1 hour

    Gastric contents identified in the mouth with pH less than 4

  7. 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 was recorded.

  8. Gastric aspirate

    Time frame: 1 hour

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

  9. Neonatal outcomes

    Time frame: 1 hour

    Neonatal birthweight. APGAR score. Umbilical venous cord pH.

Sponsors and collaborators

Lead sponsor

Wei Yu Yao

Other

Collaborators

  • KK Women's and Children's Hospital

Registry information

Official study title

Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 21, 2013
Registry last updated
May 7, 2018

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.

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