Intubation in Morbidly Obese: a Comparison of Airtraq and... | NCT02969889

Studies
Intubation in Morbidly Obese: a Comparison of Airtraq and ILMA

NCT02969889

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Feb 3, 2017Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Intubation; Difficult or Failed
Intubation Complication

Interventions

Airtraq
ILMA

Countries

Turkey (Türkiye)

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 2017

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 2016Actual

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Nov 18, 2016

First Submission Date that Met QC Criteria

Nov 18, 2016

First Posted Date

Nov 21, 2016Estimated

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 2, 2017

Last Update Posted Date

Feb 3, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial. Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.

Detailed Description

80 patients, 18-65 years of aged ASA I-III, BMI> 35 patients enrolled in this trial.

Divided into two groups ; Airtraq and ILMA .

BMI>35, upper airway tumour , respiratory infection less than ten days, excluded from this study.

patients demographic and airway variables were recoded. Patients were premedicated. After standard anesthesia induction, anesthesia was induced with propofol and fentanyl. Rocuronium was used for neuromuscular blockade.

The device insertion and intubation times, number of intubation attempts, mucosal damage, need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor complications were recorded.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intubation time	Active Comparator	handling the device till the endotracheal tube passing through the glottis	Device: Airtraq Device: ILMA
insertion time	Active Comparator	handling of the device till the glottic visualization	Device: Airtraq Device: ILMA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Airtraq	Device	video laryngoscope with a channel	insertion time intubation time

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intubation time	handling of the device till the endotracheal tube entering the glottis	1 minute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:18-65 years of age

ASA I-III
BMI>35

Exclusion Criteria:BMI<35

patients have airway tumor
patients undergoing head and neck surgery
upper respiratory infection less than 10 days prior the surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zehra Arslan	Kocaeli University Medical Faculty	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli University School of Medicine		Kocaeli		41900	Turkey (Türkiye)