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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||619 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
- 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
- blood on SLMA on removal [ Time Frame: 1 hour ]inspection for presence of blood upon removal of SLMA
- Sore throat [ Time Frame: 1 hour ]Sore throat present in recovery room
- 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 will be recorded.
- Gastric aspirate [ Time Frame: 1 hour ]Volume of gastric aspirate 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
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
|Quanzhou Women's and Children's Hospital|
|Quanzhou, Fujian, China, 700|