NCT05040412

Brief Summary

Diabetes Mellitus is known to be a risk factor for difficult laryngoscopy. Several studies showed that diabetes mellitus is responsible for 30% of difficult laryngoscopy.Insulin and oral antidiabetic drugs are two main current medication prescribed for diabetes patients.Insulin is responsible for muscle hypertrophy and weigh gain.Oral antidiabetic drugs induces muscle atrophy. The aim of this study is to evaluate the differences in the difficult laryngoscopy as a general anesthetic component in patients with Diabetes Mellitus (DM) using either insulin or oral antidiabetic drug (OAD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable diabetes-mellitus

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

January 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 2, 2021

Last Update Submit

September 2, 2021

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus, difficult laryngoscopy, insulin

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    Mallampati class,Thyromental distance,Cormack Lehane classification,Intubation time

    0-120 seconds after intubation.The time elapsed between the passage of the larygoscope through the teeth and the detection of ETCO2

Secondary Outcomes (1)

  • Intubation difficulty

    -120 seconds after intubation.The time elapsed between the passage of the larygoscope through the teeth and the detection of ETCO2

Study Arms (2)

Diabetic mellitus patients using insulin

EXPERIMENTAL

The trachea will be intubated by direct laryngoscopy.

Device: difficult laryngoscopy

Diabetic patients using oral antidiabetic drug

EXPERIMENTAL

The trachea will be intubated by direct laryngoscopy.

Device: difficult laryngoscopy

Interventions

difficult laryngoscopyDEVICE

Patients will be intubated with the direct laryngoscope.

Diabetic mellitus patients using insulinDiabetic patients using oral antidiabetic drug

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective surgery
  • Patients needing endotracheal intubation
  • Patients having eithe Type I or Type II diabetes mellitus (those who have been using insulin or OAD for at least the past 5 years)

You may not qualify if:

  • Emergency surgery
  • Difficult intubation story
  • İmpaired airway anatomy
  • Morbidly obese (BMI \> 40 kg/m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Bagcilar Egitim ve arastirma hastanesi

Istanbul, Bagcilar, 34200, Turkey (Türkiye)

Location

Related Publications (3)

  • Hashim K, Thomas M. Sensitivity of palm print sign in prediction of difficult laryngoscopy in diabetes: A comparison with other airway indices. Indian J Anaesth. 2014 May;58(3):298-302. doi: 10.4103/0019-5049.135042.

    PMID: 25024473RESULT

  • Warner ME, Contreras MG, Warner MA, Schroeder DR, Munn SR, Maxson PM. Diabetes mellitus and difficult laryngoscopy in renal and pancreatic transplant patients. Anesth Analg. 1998 Mar;86(3):516-9. doi: 10.1097/00000539-199803000-00012.

    PMID: 9495404RESULT

  • Mashour GA, Kheterpal S, Vanaharam V, Shanks A, Wang LY, Sandberg WS, Tremper KK. The extended Mallampati score and a diagnosis of diabetes mellitus are predictors of difficult laryngoscopy in the morbidly obese. Anesth Analg. 2008 Dec;107(6):1919-23. doi: 10.1213/ane.0b013e31818a9946.

    PMID: 19020139RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomised
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 10, 2021

Study Start

January 25, 2020

Primary Completion

April 30, 2020

Study Completion

May 15, 2020

Last Updated

September 10, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)