Videolaryngoscopy vs Direct Laryngoscopy for Intubation in Patients With Diabetes

NCT03336476 | Completed

• 1 other identifier: Dilek Unal Yazicioglu
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The use of videolarygoscopy (VL) as first choice for tracheal intubation versus direct laryngoscopy (DL) is a matter of debate. These two methods were compared in several studies. Videolaryngoscopes may reduce the number of failed intubations, particularly among patients presenting with a difficult airway. They improve the glottic view and may reduce airway trauma. DM is accepted as a risk factor for difficult intubation. The aim of this study is to compare VL to DL in adult patients requiring tracheal intubation for anesthesia, in terms of intubation success, glottic view quality, intubation failure, intubation time, conversion to another laringoscopy method and adverse outcomes related to tracheal intubation.

Conditions

Diabetes Mellitus

Keywords

Direct laryngoscopy; Videolaryngoscopy; Diabetes Mellitus; Intubation; Anesthesia

Outcome Measures

Primary Outcomes (3)

• intubation time

  The time elapsed between the passage of the larygoscope through the teeth and the detection of ETCO2

  0-120 seconds after intubation

• first-attempt intubation success rate

  successful intubation with the allocated device

  first second after intubation

• intubation difficulty

  number of attempts, number of operators, number of alternative techniques, CL grade, lifting force, laryngeal pressure, position of the vocal cords,

  0-120 seconds after intubation

Secondary Outcomes (4)

• glottic view quality

  during laringoscopy

• percentage of glottic opening

  during laringoscopy

• the rate of conversion to another laryngoscopy method

  5 seconds after the first attempt to intubate

• adverse outcomes related to tracheal intubation.

  1 minute after intubation

Study Arms (2)

Videolaryngoscopy

EXPERIMENTAL

Videolaryngoscopy the trachea will be intubated using a videolaringoscope

Device: Videolaryngoscopy

Direct laryngoscopy

ACTIVE COMPARATOR

Direct laringoscopy the trachea will be intubated using a laringoscope

Device: Direct laryngoscopy

Interventions

Videolaryngoscopy DEVICE

Patients will be intubated with the video laryngoscope

Videolaryngoscopy

Direct laryngoscopy DEVICE

Patients will be intubated with the direct laryngoscope

Direct laryngoscopy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective surgery
• Patients needing endotracheal intubation
• Patients having diabetes mellitus

You may not qualify if:

• Emergency surgery

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospita

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

• Lingappan K, Arnold JL, Shaw TL, Fernandes CJ, Pammi M. Videolaryngoscopy versus direct laryngoscopy for tracheal intubation in neonates. Cochrane Database Syst Rev. 2015 Feb 18;(2):CD009975. doi: 10.1002/14651858.CD009975.pub2.

  PMID: 25691129 RESULT

• Donoghue AJ, Ades AM, Nishisaki A, Deutsch ES. Videolaryngoscopy versus direct laryngoscopy in simulated pediatric intubation. Ann Emerg Med. 2013 Mar;61(3):271-7. doi: 10.1016/j.annemergmed.2012.09.008. Epub 2012 Oct 18.

  PMID: 23083969 RESULT

• van Zundert A, Maassen R, Lee R, Willems R, Timmerman M, Siemonsma M, Buise M, Wiepking M. A Macintosh laryngoscope blade for videolaryngoscopy reduces stylet use in patients with normal airways. Anesth Analg. 2009 Sep;109(3):825-31. doi: 10.1213/ane.0b013e3181ae39db.

  PMID: 19690253 RESULT

• Hofstetter C, Scheller B, Flondor M, Gerig HJ, Heidegger T, Brambrink A, Thierbach A, Wilhelm W, Wrobel M, Zwissler B. [Videolaryngoscopy versus direct laryngoscopy for elective endotracheal intubation]. Anaesthesist. 2006 May;55(5):535-40. doi: 10.1007/s00101-006-0998-3. German.

  PMID: 16688385 RESULT

• Lewis SR, Butler AR, Parker J, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation. Cochrane Database Syst Rev. 2016 Nov 15;11(11):CD011136. doi: 10.1002/14651858.CD011136.pub2.

  PMID: 27844477 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dilek Yazicioglu, Assoc Prof

  Netherlands: Ministry of Health, Welfare and Sports

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffesor

Model Details: Prospective randomised

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: November 8, 2017
• Study Start: May 9, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)