BASKA Mask Versus Endo Tracheal Tube in Gynecological Lap... | NCT03287752

Studies
BASKA Mask Versus Endo Tracheal Tube in Gynecological Laparoscopic Surgery

NCT03287752

Sponsor

Assiut University

Status

Completed

Last Update Posted

Oct 18, 2021Actual

Enrollment

66Actual

Phase

Not provided

Conditions

Ventilation

Interventions

BASKA MASK
Endotracheal tube

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

Oct 2021

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

Sep 14, 2017Actual

Primary Completion Date

Dec 29, 2019Actual

Completion Date

Dec 29, 2019Actual

First Submitted Date

Sep 14, 2017

First Submission Date that Met QC Criteria

Sep 18, 2017

First Posted Date

Sep 19, 2017Actual

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

Oct 9, 2021

Last Update Posted Date

Oct 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hala Saad Abdel-Ghaffar, Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt., Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

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

The BASKA mask (Logikal Health Products PTY Ltd., Morisset, NSW, Australia) is a novel supraglottic airway device. It has many of the features of other supraglottic airways, with a number of innovations. These include; A non-inflatable cuff, that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation, the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation more efficient.

Detailed Description

The BASKA mask incorporates an inlet that fits into the upper esophagus, and the dorsal surface of the cuff is moulded to direct any oropharyngeal contents away from the glottis and towards the side channels to which suction can be attached to facilitate aspiration of this space (Fig.1c). These features may reduce the risk of pulmonary aspiration of secretions or gastric contents that accumulate in the supraglottic area.

Compared with previous versions, these modifications have made BASKA mask airway a fairly safe and effective airway device in low-risk patients undergoing gynecologic laparoscopic surgeries

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BASKA MASK		Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant.	Device: BASKA MASK
Endotracheal tube		Patients will be anesthetized using appropriate sized cuffed oral endotracheal tube ETT.	Device: Endotracheal tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BASKA MASK	Device	Patients will be anesthetized using BASKA mask after lubrication with water soluble lubricant	BASKA MASK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak airway pressure	Peak airway pressure before and after abdominal inflation.	6 hours including preoperative, intraoperative and 4h after operation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sex: Female patients scheduled for elective gynecological laparoscopic surgery.

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

Exclusion Criteria:

Patient refusal.
History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
Patients who have high risk of regurgitation or aspiration based on history of gastro esophageal reflux, hiatus hernia, diabetes and gross obesity.
Neck pathology.
Patients who predicted difficult airway (based on a history of difficult airway, mouth opening was less than 2.5 cm, inter-incisor distance < 20 mm, cervical spine pathology, modified Mallampati class III/IV, or thyromental distance < 65 mm).
Allergy to any of the anesthetic agents used.
The possibility of being pregnant.
Heavy smoker.
Preoperative sore throat.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

females 18-60years

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Female patients scheduled for elective gynecological laparoscopic surgery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hala S Abdelghaffar, MD	Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
women health hospital, Assiut university		Asyut	Assiut Governorate	715715	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided