NCT03759990

Brief Summary

80 lean (BMI\<35) and morbidly obese (BMI\>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients and insertion and intubation times with these dievices, need for optimisation maneuvers, hemodynamic changes and minör postoperative complications were recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

November 29, 2018

Last Update Submit

March 3, 2020

Conditions

Obesity, Morbid

Keywords

videolaryngoscopeAirtraqMcGrath MACMorbid obesityintubation

Outcome Measures

Primary Outcomes (1)

  • intubation time

    2 months

Study Arms (2)

insertion time

ACTIVE COMPARATOR
Device: leanDevice: obese

intubation time

ACTIVE COMPARATOR
Device: leanDevice: obese

Interventions

leanDEVICE

Videolaryngoscope used in intubation

insertion timeintubation time
obeseDEVICE

Videolaryngoscope used in intubation

insertion timeintubation time

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • bmı 35
  • undergoing elective surgery requiring endotracheal intubation

You may not qualify if:

  • \<18 and \>65 years of age
  • bmı\<35
  • upper respiratory tract infection past ten days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kocaeli University School of Medicine

Kocaeli, 41900, Turkey (Türkiye)

Location

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Adiposity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat DistributionBody Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisBody CompositionBiochemical PhenomenaChemical PhenomenaMetabolismPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 29, 2018

First Posted

November 30, 2018

Study Start

August 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)