Videolaryngoscopy vs Direct Laryngoscopy for Intubation in Patients With Diabetes

NCT ID: NCT03336476

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-09
• Study Completion Date: 2019-05-31

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.

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Videolaryngoscopy

Videolaryngoscopy the trachea will be intubated using a videolaringoscope

Group Type: EXPERIMENTAL

Videolaryngoscopy

Intervention Type: DEVICE

Patients will be intubated with the video laryngoscope

Direct laryngoscopy

Direct laringoscopy the trachea will be intubated using a laringoscope

Group Type: ACTIVE_COMPARATOR

Direct laryngoscopy

Intervention Type: DEVICE

Patients will be intubated with the direct laryngoscope

Interventions

Videolaryngoscopy

Patients will be intubated with the video laryngoscope

Intervention Type: DEVICE

Direct laryngoscopy

Patients will be intubated with the direct laryngoscope

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Emergency surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

DILEK YAZICIOGLU

Associate Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dilek Yazicioglu, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Netherlands: Ministry of Health, Welfare and Sports

Locations

University of Health Sciences Diskapi Yildirim Beyazit Training and Research Hospita

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 25691129 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23083969 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19690253 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16688385 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27844477 (View on PubMed)

Other Identifiers

Dilek Unal Yazicioglu

Identifier Type: -

Identifier Source: org_study_id