Supreme LMA and Endotracheal Intubation Use in Caesarean Section
|ClinicalTrials.gov Identifier: NCT01858467|
Recruitment Status : Unknown
Verified May 2013 by Wei Yu Yao, Quanzhou Women and Children's Hospital.
Recruitment status was: Not yet recruiting
First Posted : May 21, 2013
Last Update Posted : May 29, 2013
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 or disease||Intervention/treatment||Phase|
|Complications; Cesarean Section||Device: Endotracheal intubation Device: Supreme Laryngeal Mask Airway||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||920 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||July 2014|
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
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858467
|Contact: Wei Yu Yao, MDemail@example.com|
|Contact: Ban L Sng, FANZCAfirstname.lastname@example.org|
|Study Director:||Shi Y Li, MD||Quanzhou Women's and Children's Hospital|