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Supreme LMA and Endotracheal Intubation Use in Caesarean Section

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Wei Yu Yao, Quanzhou Women and Children's Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01858467
First Posted: May 21, 2013
Last Update Posted: May 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
KK Women's and Children's Hospital
Information provided by (Responsible Party):
Wei Yu Yao, Quanzhou Women and Children's Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Wei Yu Yao, Quanzhou Women and Children's Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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

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

  • Sore Throat [ Time Frame: 1 hour ]
    Sore throat present in the postanaesthesia care unit

  • Patient satisfaction [ Time Frame: 1 hour ]
    Patient satisfaction with whole anaesthetic experience at 24 hours postsurgery (0 to 100%)

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

  • 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.

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

  • Neonatal outcomes [ Time Frame: 1 hour ]
    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.
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 7, 2013
First Posted: May 21, 2013
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by Wei Yu Yao, Quanzhou Women and Children's Hospital:
Airway, Cesarean

Additional relevant MeSH terms:
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants