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Airway TraumaNCT03613103

Airway Injuries After Intubation Using Videolaryngoscopy Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation

A study testing Video laryngoscopy and Direct laryngoscopy in people with Airway Trauma and Airway Complication of Anesthesia, run by Universidad de Antioquia at 1 site in Colombia.

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

Abstract Background Successful tracheal intubation during general anesthesia requires a direct laryngoscope to retract the tongue and soft tissues of the mouth to achieve a line of sight for the larynx. Generally, Macintosh blade laryngoscopy is used to achieve the tracheal intubation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Video laryngoscopy and Direct laryngoscopy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
716 participants
Where
1 siteColombia
Study dates
1 Oct 2018to 1 Dec 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Over 18 years of age.
  • Scheduled for a procedure or surgery that requires general anesthesia that requires orotracheal intubation.
  • Scheduled for non-cardiac surgery.
  • Elective surgery.

Who cannot join

  • Women in pregnancy.
  • Patient refuses to participate in the study before surgery.
  • Patients with predictors of anticipated difficult airway.
  • Head and neck surgery.
  • Go to Intensive Care Unit with endotracheal intubation.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Universidad de Antioquia

    Medellín, Antioquia

Other trials in Colombia

About this study

Official title: Airway Injuries After Intubation Using Videolaryngoscopy Highly Curved Blades Versus Direct Laryngoscopy for Adult Patients Requiring Tracheal Intubation: a Randomized Controlled Trial

Abstract Background Successful tracheal intubation during general anesthesia requires a direct laryngoscope to retract the tongue and soft tissues of the mouth to achieve a line of sight for the larynx. Generally, Macintosh blade laryngoscopy is used to achieve the tracheal intubation. However, difficulties with the tracheal intubation arise the need to use alternative laryngoscopes that use digital or fiberoptic technology, to improve the larynx visibility. Among these devices, highly curved blade videolaryngoscope uses a curved blade to retract the soft tissues of floor of the mouth and transmits a video image to a screen, achieving better larynx visibility. Also, the decrease of the force in the soft tissues with videolaryngoscope could reduce airway injures.

Objectives Our primary objective is to assess whether use of videolaryngoscopy using highly curved blades for tracheal intubation in adults requiring general anesthesia reduces risk of airways injuries compared with Macintosh direct laryngoscopy. Our secondary aim is to assess postoperative satisfaction of the patients, successful intubation at the first attempt, successful global intubation, degree of larynx visibility according to classification Cormack - Lehane and time taken to perform intubation in videolaryngoscopy vs direct laryngoscopy. Finally, we assess the risk of presenting serious adverse event with the use of videolaryngoscopy compared with Macintosh laryngoscopy in hypoxemia, bradycardia and heart arrest.

Being tested
Video laryngoscopy, Direct laryngoscopy
Keywords
video laryngoscopy, airway, injury, direct laryngoscopy, intubation, endotracheal
Medical subject headings
Wounds and Injuries

What participants receive

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

  • Video laryngoscopyDevice

    Intubation with videolaryngoscopy with highly curved blade

  • Direct laryngoscopyDevice

    Intubation with direct laryngoscopy with macintosh blade

Study groups in NCT03613103
Study groupRoleWhat they receive
Direct laryngoscopyActive comparatorIntubation with direct laryngoscopy (Conventional Intubation)
Receives: Device: Direct laryngoscopy
VideolaryngoscopyExperimentalIntubation with videolaryngoscopy (Assisted video intubation)
Receives: Device: Video laryngoscopy

What is being measured

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

  1. Number of patients with an airway injury

    Airway injury will be a composite outcome as follow: Injury in the oral cavity or injury in the laryngopharynx.

    These injuries will be evaluated using a digital camera of the oral cavity (fiber optical camera) in the immediate POP.

    A patient will be considered positive for the outcome If he/she has at least one of the following findings: Erythema, edema, ecchymosis, laceration, excoriation and / or hematoma in labial, jugal, gingival, lingual mucosa, hard and soft palate; Dental pieces injury: partial and / or total loss of the integrity of the dental piece; Larynx lesions: Edema, laceration, excoriation, erythema, ecchymosis and / or bleeding of pharyngeal laryngeal mucosa.

    Measured: 24 hours

Secondary outcomes (8)

  1. Successful intubation at the first attempt

    Number of patients with successful intubation at the first attempt.

    Measured: Immediate postoperative

  2. Global of Successful Intubation

    Number of patients with successful intubation regardless of the attempts to achieve it.

    Measured: Immediate postoperative

  3. Cormack-lehane visualization

    Degree of Cormack-lehane visualization in each patient. The degree of Cormack-Lehane visualization will be measured from I to IV in relation to the visible portion of the glottis; Grade I with total visualization and Grade IV without visualization of glottis.

    Measured: Immediate postoperative

  4. Time to achieve orotracheal intubation

    Time measured in seconds to achieve orotracheal intubation in each patient. The time interval is determined from the beginning of laryngoscopy by the anesthesiologist until the verification of tracheal intubation by capnography.

    Measured: Immediate postoperative

  5. Post-anesthetic satisfaction

    Post-anesthetic satisfaction in each patient. The Quality of Recovery scale 40 will be used to determine the degree of patient satisfaction, according to the overall and subglobal score, defined by five dimensions: patient support, comfort, emotional, physical independence and pain (includes anatomical airway site).

    Measured: Immediate postoperative

  6. Hypoxemia during induction and intubation

    Number of patients with hypoxemia during induction and intubation. Hypoxaemia is defined as an oxygen saturation measured with pulse oximetry less than 92%.

    Measured: Immediate postoperative

  7. Bradycardia during induction and intubation

    Number of patients with bradycardia during induction and intubation. Bradycardia is defined as a decrease in heart rate of less than 40 beats / minute.

    Measured: Immediate postoperative

  8. Cardiac Arrest

    Number of patients presenting cardiac arrest. Cardiac arrest is defined as the presence of any malignant rhythm: Ventricular tachycardia, ventricular fibrillation, asystole or pulseless electrical activity plus loss of carotid pulse for more than 10 seconds.

    Measured: Immediate postoperative

Timeline

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

  1. First posted2 Aug 2018
  2. Study start1 Oct 2018
  3. Primary completion31 Oct 2023
  4. Study completion1 Dec 2023

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
A single-center randomized study is performed including non-cardiac surgical patients without predictable risk of difficult mask ventilation or of difficult tracheal intubation. For direct laryngoscopy group, we use a Macintosh blade and for videolaryngoscopy group we use videolaryngoscopy highly curved blade. Induction of anesthesia is performed using myorelaxation with rocuronium. We record each five minute the vital signs in the anesthesia record. The primary outcome is observed injuries in the mucosa of the airway: Erythema, edema, ecchymosis, laceration, excoriation and / or hematoma. Injuries to dental pieces: Partial and / or total loss of tooth integrity, loosening of dental piece, damage to dental and / or aesthetic prosthetic material. Laryngeal lesions: Edema, laceration, excoriation, erythema, ecchymosis and / or bleeding pharyngeal laryngeal mucosa, arytenoid luxation. Post-intubation symptoms: Sore throat, dysphonia and / or aphonia.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
716 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03613103
Sponsor's protocol ID
Airway - 001
Status last verified
Dec 2023
First submitted
3 Jul 2018
Last updated
20 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jonathan Benumof CAH. Benumof and Hagberg's Airway Management - Jonathan Benumof, Carin A. Hagberg [Internet]. Third Edit. Carin A. Hagberg (The University of Texas MS at H, editor. Elsevier. Philadelphia, PA 19103-2899: Elsevier Inc; 2013. 1142 p. Available from: www.elsevier.com/permissions.

  • Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.

    PubMed 26556848

  • Scott J, Baker PA. How did the Macintosh laryngoscope become so popular? Paediatr Anaesth. 2009 Jul;19 Suppl 1:24-9. doi: 10.1111/j.1460-9592.2009.03026.x.

    PubMed 19572841

  • Abeyewardene L, Ganta R, Henthorn R. Direct laryngoscopy with the aid of a fiberoptic bronchoscope for tracheal intubation. Anesth Analg. 1996 Sep;83(3):665. doi: 10.1097/00000539-199609000-00066. No abstract available.

    PubMed 8780318

  • Parasa M, Yallapragada SV, Vemuri NN, Shaik MS. Comparison of GlideScope video laryngoscope with Macintosh laryngoscope in adult patients undergoing elective surgical procedures. Anesth Essays Res. 2016 May-Aug;10(2):245-9. doi: 10.4103/0259-1162.167840.

    PubMed 27212755

  • De Jong A, Molinari N, Conseil M, Coisel Y, Pouzeratte Y, Belafia F, Jung B, Chanques G, Jaber S. Video laryngoscopy versus direct laryngoscopy for orotracheal intubation in the intensive care unit: a systematic review and meta-analysis. Intensive Care Med. 2014 May;40(5):629-39. doi: 10.1007/s00134-014-3236-5. Epub 2014 Feb 21.

    PubMed 24556912

  • Kaplan MB, Ward DS, Berci G. A new video laryngoscope-an aid to intubation and teaching. J Clin Anesth. 2002 Dec;14(8):620-6. doi: 10.1016/s0952-8180(02)00457-9.

    PubMed 12565125

  • Jarvis JL, McClure SF, Johns D. EMS Intubation Improves with King Vision Video Laryngoscopy. Prehosp Emerg Care. 2015;19(4):482-9. doi: 10.3109/10903127.2015.1005259. Epub 2015 Apr 24.

    PubMed 25909850

  • Lu Y, Jiang H, Zhu YS. Airtraq laryngoscope versus conventional Macintosh laryngoscope: a systematic review and meta-analysis. Anaesthesia. 2011 Dec;66(12):1160-7. doi: 10.1111/j.1365-2044.2011.06871.x. Epub 2011 Aug 25.

    PubMed 21883130

  • Turkstra TP, Pelz DM, Jones PM. Cervical spine motion: a fluoroscopic comparison of the AirTraq Laryngoscope versus the Macintosh laryngoscope. Anesthesiology. 2009 Jul;111(1):97-101. doi: 10.1097/ALN.0b013e3181a8649f.

    PubMed 19512871

  • Kill C, Risse J, Wallot P, Seidl P, Steinfeldt T, Wulf H. Videolaryngoscopy with glidescope reduces cervical spine movement in patients with unsecured cervical spine. J Emerg Med. 2013 Apr;44(4):750-6. doi: 10.1016/j.jemermed.2012.07.080. Epub 2013 Jan 22.

    PubMed 23351572

  • Kramer A, Muller D, Pfortner R, Mohr C, Groeben H. Fibreoptic vs videolaryngoscopic (C-MAC((R)) D-BLADE) nasal awake intubation under local anaesthesia. Anaesthesia. 2015 Apr;70(4):400-6. doi: 10.1111/anae.13016.

    PubMed 25764403

  • Hunter I, Ramanathan V, Balasubramanian P, Evans DA, Hardman JG, McCahon RA. Retention of laryngoscopy skills in medical students: a randomised, cross-over study of the Macintosh, A.P. Advance() , C-MAC((R)) and Airtraq((R)) laryngoscopes. Anaesthesia. 2016 Oct;71(10):1191-7. doi: 10.1111/anae.13589. Epub 2016 Aug 17.

    PubMed 27530359

  • Graham B. Defining and Measuring Patient Satisfaction. J Hand Surg Am. 2016 Sep;41(9):929-31. doi: 10.1016/j.jhsa.2016.07.109.

    PubMed 27570227

  • Castellanos-Olivares DA, Evangelina-Cervantes DH, Vásquez-Márquez DPI. Satisfacción anestésica como indicador de calidad de la atención médica en el paciente geriátrico. Rev Mex Anestesiol [Internet]. 2013;36(1):250-5. Available from: /www.medigraphic.com/pdfs/rma/cma-2013/cmas131be.pdf

Questions about this trial

What is this clinical trial studying?

A study testing Video laryngoscopy and Direct laryngoscopy in people with Airway Trauma and Airway Complication of Anesthesia, run by Universidad de Antioquia at 1 site in Colombia.

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 4 inclusion and 5 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 20 Dec 2023. 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 Colombia. 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?

Number of patients with an airway injury (time frame: 24 hours). 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 NCT03613103, which also lists 34 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 20 Dec 2023.

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