NCT03725540

Brief Summary

The use of supraglottic airway devices with a gastric emptying tube in gynecological laparoscopic surgeries is growing. In addition to their ease of placement, they have low airway morbidity along with sufficient airway pressure in the Trendelenburg position and so they have been determined as an alternative to the endotracheal tube.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

July 28, 2018

Last Update Submit

January 12, 2021

Conditions

Laryngeal Masks

Keywords

Laryngeal MasksOropharyngeal leak pressureI-gel laryngeal mask airway

Outcome Measures

Primary Outcomes (1)

  • Leak airway pressure

    cmH2O

    Intra-operative; after device insertion up to its removal

Secondary Outcomes (1)

  • Peak airway pressure

    Intra-operative; after device insertion up to its removal

Study Arms (2)

I-gel group

Patients will be anesthetized using an appropriate sized I-gel mask according to the manufacturer's recommendations after lubrication with a water-soluble lubricant.

Device: I-gel

BASKA Group

Patients will be anesthetized using BASKA mask after lubrication with a water-soluble lubricant.

Device: Baska_mask

Interventions

I-gelDEVICE

Patients will be anesthetized using an appropriate sized I-gel mask according to the manufacturer's recommendations after lubrication with a water-soluble lubricant.

Also known as: I-gel LMA
I-gel group
Baska_maskDEVICE

Patients will be anesthetized using BASKA mask after lubrication with a water-soluble lubricant.

Also known as: The Baska_ LMA
BASKA Group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Females, aged 18-60 years, BMI\< 30kg/m2. * ASA physical status: I-II. * Operation: gynecological laparoscopic surgery * under general anesthesia of an anticipated duration\<1h.

You may qualify if:

  • BMI\< 30kg/m2.
  • ASA physical status: I-II.
  • Operation: gynecological laparoscopic surgery
  • under general anesthesia of an anticipated duration\<1h.

You may not qualify if:

  • Patient refusal.
  • History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
  • Patients who have a high risk of regurgitation or aspiration based on a history of gastroesophageal reflux, hiatus hernia, diabetes and gross obesity.
  • Neck pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

woman health hospital , Assiut university

Asyut, 71515, Egypt

RECRUITING

Related Publications (5)

  • Schmidbauer W, Bercker S, Volk T, Bogusch G, Mager G, Kerner T. Oesophageal seal of the novel supralaryngeal airway device I-Gel in comparison with the laryngeal mask airways Classic and ProSeal using a cadaver model. Br J Anaesth. 2009 Jan;102(1):135-9. doi: 10.1093/bja/aen319. Epub 2008 Nov 16.

    PMID: 19011262BACKGROUND

  • Joshi NA, Baird M, Cook TM. Use of an i-gel for airway rescue. Anaesthesia. 2008 Sep;63(9):1020-1. doi: 10.1111/j.1365-2044.2008.05668.x. No abstract available.

    PMID: 18699884BACKGROUND

  • Alexiev V, Salim A, Kevin LG, Laffey JG. An observational study of the Baska(R) mask: a novel supraglottic airway. Anaesthesia. 2012 Jun;67(6):640-5. doi: 10.1111/j.1365-2044.2012.07140.x.

    PMID: 22563956BACKGROUND

  • Pandit JJ. If it hasn't failed, does it work? On 'the worst we can expect' from observational trial results, with reference to airway management devices. Anaesthesia. 2012 Jun;67(6):578-83. doi: 10.1111/j.1365-2044.2012.07155.x. No abstract available.

    PMID: 22563955BACKGROUND

  • Janakiraman C, Chethan DB, Wilkes AR, Stacey MR, Goodwin N. A randomised crossover trial comparing the i-gel supraglottic airway and classic laryngeal mask airway. Anaesthesia. 2009 Jun;64(6):674-8. doi: 10.1111/j.1365-2044.2009.05898.x.

    PMID: 19453322BACKGROUND

Study Officials

  • Hala Abdelghaffar, MD

    Professor of anesthesia, faculty of medicine, Assiut university, Egypt.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hala S Abdel-Ghaffar, MD

CONTACT

01003812011hallasaad@yahoo.com

ghada aboelfadl, MD

CONTACT

01005802086ghadafadl77@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2018

First Posted

October 31, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)