Supreme LMA Use in Urgent Caesarean Section

NCT ID: NCT02026882

Last Updated: 2020-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

584 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Airway Morbidity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supreme Laryngeal Mask Airway

Supreme Laryngeal Mask Airway with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.

Group Type OTHER

Supreme Laryngeal Mask Airway

Intervention Type DEVICE

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

Interventions

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Supreme Laryngeal Mask Airway

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role collaborator

QuanZhou Women and Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei Yu Yao

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Quanzhou Women's and Children's Hospital

Quanzhou, Fujian, China

Site Status

Countries

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China

References

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Lim MJ, Tan HS, Tan CW, Li SY, Yao WY, Yuan YJ, Sultana R, Sng BL. The effects of labor on airway outcomes with Supreme laryngeal mask in women undergoing cesarean delivery under general anesthesia: a cohort study. BMC Anesthesiol. 2020 Aug 26;20(1):213. doi: 10.1186/s12871-020-01132-5.

Reference Type DERIVED
PMID: 32847548 (View on PubMed)

Tan HS, Li SY, Yao WY, Yuan YJ, Sultana R, Han NR, Sia ATH, Sng BL. Association of Mallampati scoring on airway outcomes in women undergoing general anesthesia with Supreme laryngeal mask airway in cesarean section. BMC Anesthesiol. 2019 Jul 8;19(1):122. doi: 10.1186/s12871-019-0796-5.

Reference Type DERIVED
PMID: 31286890 (View on PubMed)

Li SY, Yao WY, Yuan YJ, Tay WS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Supreme laryngeal mask airway use in general Anesthesia for category 2 and 3 Cesarean delivery: a prospective cohort study. BMC Anesthesiol. 2017 Dec 19;17(1):169. doi: 10.1186/s12871-017-0460-x.

Reference Type DERIVED
PMID: 29258438 (View on PubMed)

Other Identifiers

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2013-11-11

Identifier Type: -

Identifier Source: org_study_id

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