NCT04021407

Brief Summary

Nowadays, supraglottic airway devices are simple and effective alternatives to endotracheal intubation. Both laryngeal mask airway LMA and air-Q airway are supraglottic airway devices that can be used to maintain and protect airways from aspiration of secretions and blood during DCR surgery. The present study was designed to compare standard LMA versus air Q as regards the sealing effect and aspiration of blood in DCR surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

July 10, 2019

Last Update Submit

July 12, 2019

Conditions

Keywords

AirQLMAdacrocystorhinostomy surgery

Outcome Measures

Primary Outcomes (1)

  • Oro pharyngeal leak pressure in (cmH2O)

    By setting the pop-off valve to limit peak airway pressure to 40 cm H2O and allowing airway pressure to increase at a fresh gas flow of 3 L/min until audible noise was heard over the mouth and no further increase in airway pressure is observed.

    Just after insertion of supraglottic airway devices

Secondary Outcomes (1)

  • Leak fraction in (%)

    Just after insertion of supraglottic airway devices

Study Arms (2)

LMA

ACTIVE COMPARATOR

36 patients were ventilated with LMA during dacryocystorhinostomy surgery

Device: LMA group

AirQ

ACTIVE COMPARATOR

36 patients each were ventilated with air Q airway during dacryocystorhinostomy surgery

Device: AirQ group

Interventions

LMA groupDEVICE

patients were ventilated with LMA

LMA

patients were ventilated with AirQ airway

AirQ

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both sex
  • Age: 18-60 years
  • ASA I-II
  • Patients scheduled for dacryocystorhinostomy surgery

You may not qualify if:

  • Any pathology of the neck, upper respiratory tract, upper alimentary tract
  • Patients with a history of gastric regurgitation, heartburn
  • Morbid obese,
  • Patients with esophageal reflux (hiatus hernia)
  • Anticipating difficult airway management
  • Patients with coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashraf Eskandr

Shibīn al Kawm, Monufia Governorate, 1234, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participiant Investigator
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of anesthesia, icu

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 16, 2019

Study Start

April 1, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations