Supreme LMA and Endotracheal Intubation Use in Caesarean Section

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by QuanZhou Women and Children's Hospital
Sponsor:
Collaborator:
KK Women's and Children's Hospital
Information provided by (Responsible Party):
Wei Yu Yao, Quanzhou Women and Children's Hospital
ClinicalTrials.gov Identifier:
NCT01858467
First received: April 7, 2013
Last updated: May 26, 2013
Last verified: May 2013
  Purpose

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%.


Condition Intervention
Complications; Cesarean Section
Device: Endotracheal intubation
Device: Supreme Laryngeal Mask Airway

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by QuanZhou Women and Children's Hospital:

Primary Outcome Measures:
  • First attempt insertion success rate [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    An attempt is defined as insertion and complete withdrawal of the device from the patient's airway


Secondary Outcome Measures:
  • Time to effective airway placement [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Interval from when the device was picked up until appearance of the first end-tidal carbon dioxide wave form

  • Aspiration [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    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

  • blood on SLMA on removal [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    inspection for presence of blood on Supreme Laryngeal Mask Airway on removal

  • Sore Throat [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Sore throat present in the postanaesthesia care unit

  • Patient satisfaction [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Patient satisfaction with whole anaesthetic experience at 24 hours postsurgery (0 to 100%)

  • Regurgitation [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Gastric contents identified in the mouth with pH less than 4

  • Seal pressure [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    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.

  • Gastric aspirate [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Volume of gastric aspiration using gastric tube and pH of gastric aspirate using litmus paper

  • Neonatal outcomes [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Neonatal birthweight. APGAR score. Umbilical venous cord pH.


Estimated Enrollment: 920
Study Start Date: May 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supreme Laryngeal Mask Airway
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
Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.
Other Name: Supreme Laryngeal Mask Airway
Active Comparator: Endotracheal Intubation
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
Portex endotracheal tube 6.5mm or 7.0mm internal diameter
Other Name: Endotracheal intubation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858467

Contacts
Contact: Wei Yu Yao, MD +8613959790011 ywyzxy@sina.com
Contact: Ban L Sng, FANZCA +6563941081 blsngdr@yahoo.com.sg

Sponsors and Collaborators
Wei Yu Yao
KK Women's and Children's Hospital
Investigators
Study Director: Shi Y Li, MD Quanzhou Women's and Children's Hospital
  More Information

No publications provided

Responsible Party: Wei Yu Yao, Dr, Quanzhou Women and Children's Hospital
ClinicalTrials.gov Identifier: NCT01858467     History of Changes
Other Study ID Numbers: 2012-10-27
Study First Received: April 7, 2013
Last Updated: May 26, 2013
Health Authority: China: Ethics Committee

Keywords provided by QuanZhou Women and Children's Hospital:
Airway, Cesarean

ClinicalTrials.gov processed this record on September 16, 2014