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Diabetes MellitusNCT03336476

Videolaryngoscopy vs Direct Laryngoscopy for Intubation in Patients With Diabetes

A study testing Videolaryngoscopy and Direct laryngoscopy in people with Diabetes Mellitus, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Videolaryngoscopy and Direct laryngoscopy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteTurkey (Türkiye)
Study dates
9 May 2018to 31 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Emergency surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospita

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Can Videolaryngoscopy be the First Choice for Tracheal Intubation in Patients With Diabetes

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.

Read the detailed description

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. First attempt intubation success and glottic visualization with VL versus DL by pediatric emergency medicine providers in simulated patients were evaluated and it was concluded that VL was associated with greater first-attempt success during intubation by pediatric emergency physicians on an adult simulator. The ease of viewing the glottis under direct vision during conventional laryngoscopy with the quality of indirectly viewing on a monitor during laryngoscopy with a Macintosh videolaryngoscope was compared in a multicenter study. The results were that VL can lead to better viewing conditions but in rare cases it may result in worse viewing conditions. The study evaluating the efficacy and safety of VL compared to DL in decreasing the time and attempts required and increasing the success rate for endotracheal intubation in neonates concluded that there was insufficient evidence to recommend or refute the use of VL for endotracheal intubation in neonates. Diverse videolaryngoscopes where also compared in patients undergoing tracheal intubation for elective surgery: the GlideScope Ranger (GlideScope, Bothell, WA), the V-MAC Storz Berci DCI (Karl Storz, Tuttlingen, Germany), and the McGrath (McGrath series 5, Aircraft medical, Edinburgh, UK) and tested whether it is feasible to intubate the trachea of patients with indirect videolaryngoscopy without using a stylet. The authors concluded that the trachea of a large proportion of patients with normal airways can be intubated successfully with certain VL blades without using a stylet, although the three studied VL's clearly differ in outcome. The Storz VL displaces soft tissues in the fashion of a classic Macintosh scope, affording room for tracheal tube insertion and limiting the need for stylet use compared with the other two scopes. Although VL's offer several advantages, including better visualization of the glottic entrance and intubation conditions, a good laryngeal view does not guarantee easy or successful tracheal tube insertion. Three different videolarygoscope devices were compared to direct laringoscopy in obese patients undergoing bariatric surgery: Video Mac and GlideScope required fewer intubation attempts that DL and Video Mac provide shorter intubation times and improved glottis view compared to DL. A recent metanalysis stated that videolaryngoscopes may reduce the number of failed intubations, particularly among patients presenting with a difficult airway. They improve the glottic view and may reduce laryngeal/airway trauma. However currently, no evidence indicates that use of a VLS reduces the number of intubation attempts or the incidence of hypoxia or respiratory complications, and no evidence indicates that use of a VL's affects time required for intubation. DM is accepted as a risk factor for difficult intubation.

The aim of this study is to compare VL to DL in adult diabetic patients requiring tracheal intubation for anesthesia, in terms of intubation time, intubation success, glottic view quality, intubation failure, conversion to another laringoscopy method and adverse outcomes related to tracheal intubation.

METHODS After obtaining ethical approval and written informed patient consent, consecutive patients having diabetes mellitus (DM) and requiring elective intubation for anesthesia will be randomly allocated to either the videolaryngoscopy (Group VL) or the direct larngoscopy (Macintosh laryngoscope) (Group DL). Age, gender, body mass index, American Society of Anesthesiologists (ASA) physiologic classification, the duration of DM will be recorded. The patients will be evaluated for difficult airway predictors and the following parameters will be recorded: Malampati class, thyromental distance, sternomental distance, mandibulohyoid distance, interincisor distance, neck circumference, the ability of upper lip overbite and lower lip overbite, the presence of limited neck extension. Fentanyl-propofol-rocuronium will be used for anesthesia induction. After subsequent positive-pressure ventilation using a face mask and an oxygen-air-sevoflurane mixture for 3 min, the trachea will be intubated according to group allocation using either DL (Macintosh laryngoscope) or VL (CMAC). During intubation, the following data will be documented: intubation time, number of intubation attempts, use of extra tools to facilitate intubation, conversion to another laryngoscopy method,intubation difficulty and the quality of the view of the glottis will be assessed according to the Cormack and Lehane scoring system and the percentage of glottic opening. Adverse events related to tracheal intubation will be also evaluated: desaturation (SPO2<94), hypercabia (ETCO2>35), hypertension (mean arterial pressure >20% above baseline values), tachycardia (heart rate >20% above baseline values), new onset arrhythmia, laryngospasm, bronchospasm, airway trauma and sore throat in PACU). The primary outcome measure is the time to intubation; first-attempt intubation success and ease of intubation, secondary outcome measures are the glottic view guality, conversion to another laryngoscopy method and adverse outcomes related to tracheal intubation.

Being tested
Videolaryngoscopy, Direct laryngoscopy
Keywords
Direct laryngoscopy, Videolaryngoscopy, Diabetes Mellitus, Intubation, Anesthesia
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VideolaryngoscopyDevice

    Patients will be intubated with the video laryngoscope

  • Direct laryngoscopyDevice

    Patients will be intubated with the direct laryngoscope

Study groups in NCT03336476
Study groupRoleWhat they receive
VideolaryngoscopyExperimentalVideolaryngoscopy the trachea will be intubated using a videolaringoscope
Receives: Device: Videolaryngoscopy
Direct laryngoscopyActive comparatorDirect laringoscopy the trachea will be intubated using a laringoscope
Receives: Device: Direct laryngoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intubation time

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

    Measured: 0-120 seconds after intubation

  2. first-attempt intubation success rate

    successful intubation with the allocated device

    Measured: first second after intubation

  3. intubation difficulty

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

    Measured: 0-120 seconds after intubation

Secondary outcomes (4)
  1. glottic view quality

    Cormack Lehane

    Measured: during laringoscopy

  2. percentage of glottic opening

    the percentage of glottic opening seen, defined by the linear span from the anterior commisure to the interarytenoid notch

    Measured: during laringoscopy

  3. the rate of conversion to another laryngoscopy method

    the intubation device will be changed if the anesthetist fails to intubate with the allocated device

    Measured: 5 seconds after the first attempt to intubate

  4. adverse outcomes related to tracheal intubation.

    Hypertension, tachycardia, desaturation, hypercarbia, airway trauma, laryngospasm, bronchospasm, sore throat,

    Measured: 1 minute after intubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start9 May 2018
  3. Primary completion31 May 2019
  4. Study completion31 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomised
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03336476
Sponsor's protocol ID
Dilek Unal Yazicioglu
Status last verified
Apr 2019
First submitted
5 Nov 2017
Last updated
4 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25691129
  • 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.

    PubMed 23083969
  • 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.

    PubMed 19690253
  • 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.

    PubMed 16688385
  • 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.

    PubMed 27844477

Questions about this trial

What is this clinical trial studying?

A study testing Videolaryngoscopy and Direct laryngoscopy in people with Diabetes Mellitus, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intubation time (time frame: 0-120 seconds after intubation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03336476, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.

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