Supreme LMA and Endotracheal Intubation Use in Caesarean Section

NCT01858467 | Completed DMC

• 1 other identifier: 2012-10-27
• Study Type: interventional
• Target: 920
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Airway, Cesarean

Outcome Measures

Primary Outcomes (1)

• First attempt insertion success rate

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

  1 hour

Secondary Outcomes (9)

• Time to effective airway placement

  1 hour

• Aspiration

  1 hour

• blood on SLMA on removal

  1 hour

• Sore Throat

  1 hour

• Patient satisfaction

  1 hour

Study Arms (2)

Supreme Laryngeal Mask Airway

EXPERIMENTAL

Supreme Laryngeal Mask Airway (Airway Device) with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane.

Device: Supreme Laryngeal Mask Airway

Endotracheal Intubation

ACTIVE COMPARATOR

Endotracheal intubation (Airway Device) using Macintosh Laryngoscope with tracheal tube with gastric tube insertion after placement. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane.

Device: Endotracheal intubation

Interventions

Endotracheal intubation DEVICE

Portex endotracheal tube 6.5mm or 7.0mm internal diameter

Endotracheal Intubation

Supreme Laryngeal Mask Airway DEVICE

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

Supreme Laryngeal Mask Airway

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wei Yu Yao: lead
• KK Women's and Children's Hospital: collaborator

Related Publications (1)

• Yao WY, Li SY, Yuan YJ, Tan HS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Comparison of Supreme laryngeal mask airway versus endotracheal intubation for airway management during general anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2019 Jul 8;19(1):123. doi: 10.1186/s12871-019-0792-9.

  PMID: 31286883 DERIVED

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Shi Y Li, MD

  Quanzhou Women's and Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 7, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 7, 2018

Record last verified: 2018-05