Supreme LMA Use in Urgent Caesarean Section

Airway Morbidity Clinical Trial

Official title:

Supreme Laryngeal Mask Use in Urgent Caesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026882
• Other study ID #: 2013-11-11
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: July 2020
• Source: QuanZhou Women and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: May 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

Device:
• Supreme Laryngeal Mask Airway
Supreme Laryngeal Mask Airway. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.

Locations

Country	Name	City	State
China	Quanzhou Women's and Children's Hospital	Quanzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
QuanZhou Women and Children's Hospital	KK Women's and Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First attempt insertion success rate	An attempt is defined as insertion and 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 waveform	1 hour
Secondary	Aspiration	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	1 hour
Secondary	blood on SLMA on removal	inspection for presence of blood upon removal of SLMA	1 hour
Secondary	Sore throat	Sore throat present in recovery room	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 will be recorded.	1 hour
Secondary	Gastric aspirate	Volume of gastric aspirate 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