Supreme LMA and Endotracheal Intubation Use in Caesarean Section

Complications; Cesarean Section Clinical Trial

Official title:

Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858467
• Other study ID #: 2012-10-27
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: July 2014

Study information

• Verified date: May 2018
• Source: QuanZhou Women and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 920
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Complications; Cesarean Section

Intervention

Device:
• Endotracheal intubation
Portex endotracheal tube 6.5mm or 7.0mm internal diameter
• Supreme Laryngeal Mask Airway
Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wei Yu Yao	KK Women's and Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First attempt insertion success rate	An attempt is defined as insertion and complete withdrawal of the device from the patient's airway	1 hour
Secondary	Time to effective airway placement	Interval from when the device was picked up until appearance of the first end-tidal carbon dioxide wave form	1 hour
Secondary	Aspiration	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	1 hour
Secondary	blood on SLMA on removal	inspection for presence of blood on Supreme Laryngeal Mask Airway on removal	1 hour
Secondary	Sore Throat	Sore throat present in the postanaesthesia care unit	1 hour
Secondary	Patient satisfaction	Patient satisfaction with whole anaesthetic experience at 24 hours postsurgery (0 to 100%)	1 hour
Secondary	Regurgitation	Gastric contents identified in the mouth with pH less than 4	1 hour
Secondary	Seal pressure	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.	1 hour
Secondary	Gastric aspirate	Volume of gastric aspiration using gastric tube and pH of gastric aspirate using litmus paper	1 hour
Secondary	Neonatal outcomes	Neonatal birthweight. APGAR score. Umbilical venous cord pH.	1 hour