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Supreme LMA Use in Urgent Caesarean Section

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ClinicalTrials.gov Identifier: NCT02026882
Recruitment Status : Completed
First Posted : January 3, 2014
Last Update Posted : October 4, 2017
Sponsor:
Collaborator:
KK Women's and Children's Hospital
Information provided by (Responsible Party):
Wei Yu Yao, QuanZhou Women and Children's Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Airway Morbidity Device: Supreme Laryngeal Mask Airway Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 619 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Supreme Laryngeal Mask Use in Urgent Caesarean Section
Study Start Date : December 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Supreme Laryngeal Mask Airway
Supreme Laryngeal Mask Airway with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.
Device: Supreme Laryngeal Mask Airway
Supreme Laryngeal Mask Airway. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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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
  • 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

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): NCT02026882


Locations
China, Fujian
Quanzhou Women's and Children's Hospital
Quanzhou, Fujian, China, 700
Sponsors and Collaborators
QuanZhou Women and Children's Hospital
KK Women's and Children's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wei Yu Yao, Dr, QuanZhou Women and Children's Hospital
ClinicalTrials.gov Identifier: NCT02026882     History of Changes
Other Study ID Numbers: 2013-11-11
First Posted: January 3, 2014    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

Keywords provided by Wei Yu Yao, QuanZhou Women and Children's Hospital:
Airway, Caesarean

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