Ventilation With Supraglottic Airway Devices | NCT04421261

Studies
Ventilation With Supraglottic Airway Devices

NCT04421261

Sponsor

Reham Ali Abdelhaleem Abdelrahman

Status

Completed

Last Update Posted

Feb 26, 2024Actual

Enrollment

140Actual

Phase

Not provided

Conditions

Laryngeal Masks Comparison

Interventions

Air-Q Self Pressurized Airway Device with Blocker
Proseal Laryngeal Mask Airway

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2020Actual

Primary Completion Date

Jul 1, 2021Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Jun 4, 2020

First Submission Date that Met QC Criteria

Jun 5, 2020

First Posted Date

Jun 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2024

Last Update Posted Date

Feb 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Reham Ali Abdelhaleem Abdelrahman, Anesthesia lecturer, Cairo UniversitySponsor-Investigator

Lead Sponsor

Reham Ali Abdelhaleem AbdelrahmanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. Oropharyngeal leak pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed in neutral, flexion, extension and lateral positions in both groups.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Air-Q Self Pressurized Airway Device with Blocker			Device: Air-Q Self Pressurized Airway Device with Blocker
Proseal Laryngeal Mask Airway			Device: Proseal Laryngeal Mask Airway

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Air-Q Self Pressurized Airway Device with Blocker	Device	used in low risk adult females undergoing elective surgeries	Air-Q Self Pressurized Airway Device with Blocker

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oropharyngeal leak pressure	pressure at which air leak starts to occur	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult female patients ASA I&II.
age: 18-55 years old.
BMI< 35.
undergoing elective surgeries.

Exclusion Criteria:

Patients with history of upper respiratory tract infections and obstructive sleep apnea.
Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation &heart burn, those with esophageal reflux or hiatus hernia.
Patients with coagulation disorders.
Patients with El-Ganzouri airway score ≥ 5 will.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Adult female patients who will be admitted through outpatient clinic of Kasr alainy hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of anesthesia, Surgical ICU and Pain Management		Cairo		11562	Egypt