Intubation; Difficult or FailedNCT04386356
A Comparative Study of Airtraq Versus Macintosh Laryngoscope for Endotracheal Intubation by First Year Resident
A study testing Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscope in people with Intubation; Difficult or Failed and Intubation Complication, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
This study evaluates the learning and performance of tracheal intubation by first year anaesthesia trainee in Nepalese population using either Airtraq or Macintosh laryngoscopes. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Intubation Complication
- What is being tested?
- Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscope
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNepal
- Study dates
- 1 Feb 2020to 1 Dec 2020
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA physical status I and II
- Age group 16-65 years of either gender
- Patient requiring orotracheal intubation under general anaesthesia.
Who cannot join
- Patient having respiratory tract (oropharynx, larynx) pathology,
- Patient with predicted difficult airway (such as mouth opening <2 cm),
- Patient having gastroesophageal reflux disease, hiatus hernia, and pregnancy.
Trial locations and contacts
1 site in 1 country.
Nepal1 site, 1 recruiting
- Recruiting
B P Koirala Institute of Health Sciences
Dharān, Koshi, 56700
Birendra Prasad Sah, MD, +977-9852049693, drbirendrasah@bpkihs.edu
Balkrishna Bhattarai, +977-9842022693, bhattaraibk@bpkihs.edu
About this study
Official title: Airtraq Video Laryngoscope Versus Macintosh Laryngoscope for Endotracheal Intubation by First Year Anaesthesia Trainee in Nepalese Population: A Comparative Study
This study evaluates the learning and performance of tracheal intubation by first year anaesthesia trainee in Nepalese population using either Airtraq or Macintosh laryngoscopes.
Read the detailed description
The airway is primarily a conduit for air to reach the lungs. Maintaining a stable, patent airway is a fundamental element of safe perioperative care for all anesthesiologists. Though maintaining airway patency seems conceptually straightforward, a wide variety of clinical circumstances, patients, and tools can make the task of ensuring a stable, open airway under all clinical conditions extremely challenging.
In spite of endotracheal intubation being a lifesaving skill, problems like delayed intubation, misplaced tracheal tube, or airway trauma are frequently encountered, and can cause death or hypoxic brain damage. The magnitude of problems during airway management constitute 17% of anaesthesia closed claims in UK, with difficult intubation being the most common at a rate of 5%.The American Society of Anesthesiologists' Closed Claims Project (ASACCP) reports that though the proportion of claims for respiratory complications decreased from 34% in the 1970s to 15% in the 1990s, the 'big three' (inadequate ventilation, oesophageal intubation, and difficult tracheal intubation) still accounted for >50% of claims leading to death or permanent brain damage.
Direct laryngoscopy (DL) remains the gold standard technique for securing the airway. Successful DL involves the creation of a new (non-anatomic) visual axis, through maximal alignment of the axes of the oral and pharyngeal cavities and displacement of the tongue that requires manipulations of head, neck and larynx and other stressful movements. These manipulations of the airway have numerous adverse implications including significant hemodynamic disturbances, cervical instability, injury to oral and pharyngeal tissues, and dental damage. It is thus, a complicated technical skill with a variable learning curve and requires regular training, experience, and practice to acquire and maintain.
The video laryngoscope (VL) is a recently developed device with a camera and light source on the tip of its blade that provides indirect glottic view. The Airtraq laryngoscope is a recently developed video laryngoscope. It has an anatomically shaped blade which contains two parallel channels, one, the guiding channel, for the insertion of the endotracheal tube (ETT) and the other, the optical channel, containing a series of lenses, prisms, and mirrors that transfer the image from the illuminated tip to a proximal viewfinder, giving a high-quality wide-angle view of the glottis and surrounding structures.
As compared to DL, Airtraq VL requires the application of lesser force to the base of the tongue and is thus less likely to stimulate stress response and induce local tissue injury, produces less cervical movement, and has a faster learning curve relative to DL. It has also been demonstrated to be beneficial in the difficult airway scenario, when compared with the Macintosh laryngoscope, by reducing the number of failed intubations, the duration of intubation attempts and the amount of airway manipulation required, making them suitable for use by medical personnel who intubate infrequently.
The purpose of this study is to evaluate learning and performance of tracheal intubation by first year anaesthesia trainee using either Airtraq VL or Macintosh laryngoscopes.
- Being tested
- Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscope
- Keywords
- Macintosh laryngoscope, Airtraq video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscopeDevice
Tracheal intubation will be performed by first year anaesthesia trainee using either Macintosh laryngoscope or Airtraq video laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer on one group of patients.
| Study group | Role | What they receive |
|---|---|---|
| Orotracheal intubation with macintosh laryngoscope | No intervention | Following standard intubation protocol, tracheal intubation will be performed by first year anaesthesia trainee using Macintosh laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer on one group of patients. Duration of intubation attempt, failed intubation, optimization maneuvers required to perform tracheal intubation, glottic view according to the Cormack and Lehane grading will be evaluated. Similarly, the maximum fall in oxygen saturation during intubation, HR, SBP and DBP will be documented immediately following intubation and then every 5 minutes till the end of surgery. The occurrence of minor complications (visible trauma to lip or oral mucosa, and presence of blood on laryngoscope blade), and the postoperative sore throat and hoarseness will be evaluated at the end of surgery in the postoperative recovery room. |
| Orotracheal intubation with Airtraq Video Laryngoscope | Active comparator | Following standard intubation protocol, tracheal intubation will be performed by first year anaesthesia trainee using Airtraq video laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer on one group of patients.
Duration of intubation attempt, failed intubation, optimization maneuvers required to perform tracheal intubation, glottic view according to the Cormack and Lehane grading will be evaluated. Similarly, the maximum fall in oxygen saturation during intubation, HR, SBP and DBP will be documented immediately following intubation and then every 5 minutes till the end of surgery. The occurrence of minor complications (visible trauma to lip or oral mucosa, and presence of blood on laryngoscope blade), and the postoperative sore throat and hoarseness will be evaluated at the end of surgery in the postoperative recovery room. Receives: Device: Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time required for tracheal intubation.
Duration of intubation attempt will be defined as the time elapsed from insertion of the blade of laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords and confirmed by chest rise, auscultation, and square wave capnography
Measured: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
Secondary outcomes (7)
Intubation difficulty scale (IDS) score18 for each device.
Number of attempts >1: N1; Each additional attempts add 1 point Number of operators >1: N2; Each additional operators add 1 point Number of alternative techniques: N3; Each techniques add 1 point Cormack Lehane grade: N4; 0 if successful blind intubation; 1 if grade at first attempt is 1 Lifting force required : N5; 0 if normal force required; 1 if increased force required Laryngeal pressure : N6; 0 if not applied; 1 if applied Vocal cord mobility : N7; 0 if abduction 1 if adduction Total IDS : Sum of scores = N1+N2+N3+N4+N5+N6+N7
Measured: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
Rate of successful placement of endotracheal tube.
Successful placement will be confirmed by chest rise, auscultation, and square wave on capnography.
Measured: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
Number of optimization maneuvers required to perform tracheal intubation.
Optimization maneuvers required to perform tracheal intubation will be assessed on a score of 0 to 2:
- No maneuvers required.
- External laryngeal pressure.
- Use of stylet.
Measured: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
Changes in heart rate before and immediately following intubation.
The blood pressure will be recorded before intubation and assessed again immediately after intubation, and every 5 minutes till the end of the surgery
Measured: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
Incidence of trauma to the airway.
The occurrence of minor complications (visible trauma to lip or oral mucosa, and presence of blood on laryngoscope blade), and the postoperative sore throat and hoarseness will be evaluated at the end of surgery in the postoperative recovery room.
Measured: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
Changes in systolic, diastolic and mean blood pressure before and immediately following intubation
The blood pressure will be recorded before intubation and assessed again immediately after intubation, and every 5 minutes till the end of the surgery
Measured: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
Changes in oxygen saturation before and immediately following intubation
The oxygen saturation will be recorded before intubation and assessed again immediately after intubation, and every 5 minutes till the end of the surgery
Measured: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Feb 2020
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- First year anaesthesia trainee are those residents in their first year of anaesthesia training and has not had any prior experience using either laryngoscope. They will be given adequate training and instructions before intubation on patients. On the day of surgery, the baseline airway variables and the baseline hemodynamic values will be recorded. An investigator not involved in assessing the patient outcome will open the sealed envelope according to the serial number of the patient enrolled into the study. Following standard induction technique of preoxygenation with 100% oxygen, injection fentanyl, injection propofol, injection veruronium and mixture of isoflurane and oxygen, tracheal intubation will then be performed by first year anaesthesia trainee using either Airtraq or Macintosh laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sabin Bhandari, B.P. Koirala Institute of Health Sciences
- Investigators
- Sabin Bhandari, MD, Principal investigator, Assistant Professor, Department of Anaesthesiology and Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386356
- Sponsor's protocol ID
- 490/076/077
- Status last verified
- May 2020
- First submitted
- 25 Apr 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rosenblatt WH, Sukhupragaran W. Airway management. In: Barash PG, Cullen BF, Stoelting RK, Cahalan MK, Stock MC, Ortega R, editors. Clinical Anesthesia. 7th ed. Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2013. p. 774.
Berry JM, Harvey S. Laryngoscopic Orotracheal and Nasotracheal Intubation. In: Benumof and Hagberg"s Airway Management; Hagberg CA, Gabel JC, editors, 3rd ed. Philadelphia, PA: Elsevier/Saunders; 2013. p.346-347.
Zafirova Z, Tung A. The Difficult Airway: Definitions and Algorithms. In: Glick DB, Cooper RM, Ovassapian A, editors. The difficult airway. New York: Springer; 2013. p.1.
Woodall NM, Benger JR, Harper JS, et al. Airway management complications during anaesthesia, in intensive care units and in emergency departments in the UK. Trends in Anaesthesia and Critical Care. 2012; 2(2), 58-64. doi:10.1016/j.tacc.2012.02.005
Metzner J, Posner KL, Lam MS, Domino KB. Closed claims' analysis. Best Pract Res Clin Anaesthesiol. 2011 Jun;25(2):263-76. doi: 10.1016/j.bpa.2011.02.007.
PubMed 21550550Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.
PubMed 21447489Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012 Dec;109 Suppl 1:i68-i85. doi: 10.1093/bja/aes393.
PubMed 23242753Macintosh RR. A NEW LARYNGOSCOPE. The Lancet. 1943; 241(6233), 205.
Miller RA: A new laryngoscope. Anesthesiology. 1941, 2 (3): 310-316. 10.
Chemsian R, Bhananker S, Ramaiah R. Videolaryngoscopy. Int J Crit Illn Inj Sci. 2014 Jan;4(1):35-41. doi: 10.4103/2229-5151.128011.
PubMed 24741496Niforopoulou P, Pantazopoulos I, Demestiha T, Koudouna E, Xanthos T. Video-laryngoscopes in the adult airway management: a topical review of the literature. Acta Anaesthesiol Scand. 2010 Oct;54(9):1050-61. doi: 10.1111/j.1399-6576.2010.02285.x. Epub 2010 Jul 28.
PubMed 20887406Maharaj CH, Buckley E, Harte BH, Laffey JG. Endotracheal intubation in patients with cervical spine immobilization: a comparison of macintosh and airtraq laryngoscopes. Anesthesiology. 2007 Jul;107(1):53-9. doi: 10.1097/01.anes.0000267529.71756.f0.
PubMed 17585215Paolini JB, Donati F, Drolet P. Review article: video-laryngoscopy: another tool for difficult intubation or a new paradigm in airway management? Can J Anaesth. 2013 Feb;60(2):184-91. doi: 10.1007/s12630-012-9859-5. Epub 2012 Dec 12.
PubMed 23233395Nouruzi-Sedeh P, Schumann M, Groeben H. Laryngoscopy via Macintosh blade versus GlideScope: success rate and time for endotracheal intubation in untrained medical personnel. Anesthesiology. 2009 Jan;110(1):32-7. doi: 10.1097/ALN.0b013e318190b6a7.
PubMed 19104167Kaplan MB, Hagberg CA, Ward DS, Brambrink A, Chhibber AK, Heidegger T, Lozada L, Ovassapian A, Parsons D, Ramsay J, Wilhelm W, Zwissler B, Gerig HJ, Hofstetter C, Karan S, Kreisler N, Pousman RM, Thierbach A, Wrobel M, Berci G. Comparison of direct and video-assisted views of the larynx during routine intubation. J Clin Anesth. 2006 Aug;18(5):357-62. doi: 10.1016/j.jclinane.2006.01.002.
PubMed 16905081
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airtraq Video Laryngoscope Versus Macintosh Laryngoscope for Endotracheal Intubation by First Year Anaesthesia Trainee in Nepalese Population: A Comparative Study
- ClinicalTrials.gov ID
- NCT04386356
- Acronym / sponsor ID
- 490/076/077
- Keywords
- Macintosh laryngoscope, Airtraq video laryngoscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the learning and performance of tracheal intubation by first year anaesthesia trainee in Nepalese population using either Airtraq or Macintosh laryngoscopes.
Detailed description
The airway is primarily a conduit for air to reach the lungs. Maintaining a stable, patent airway is a fundamental element of safe perioperative care for all anesthesiologists. Though maintaining airway patency seems conceptually straightforward, a wide variety of clinical circumstances, patients, and tools can make the task of ensuring a stable, open airway under all clinical conditions extremely challenging.
In spite of endotracheal intubation being a lifesaving skill, problems like delayed intubation, misplaced tracheal tube, or airway trauma are frequently encountered, and can cause death or hypoxic brain damage. The magnitude of problems during airway management constitute 17% of anaesthesia closed claims in UK, with difficult intubation being the most common at a rate of 5%.The American Society of Anesthesiologists' Closed Claims Project (ASACCP) reports that though the proportion of claims for respiratory complications decreased from 34% in the 1970s to 15% in the 1990s, the 'big three' (inadequate ventilation, oesophageal intubation, and difficult tracheal intubation) still accounted for >50% of claims leading to death or permanent brain damage.
Direct laryngoscopy (DL) remains the gold standard technique for securing the airway. Successful DL involves the creation of a new (non-anatomic) visual axis, through maximal alignment of the axes of the oral and pharyngeal cavities and displacement of the tongue that requires manipulations of head, neck and larynx and other stressful movements. These manipulations of the airway have numerous adverse implications including significant hemodynamic disturbances, cervical instability, injury to oral and pharyngeal tissues, and dental damage. It is thus, a complicated technical skill with a variable learning curve and requires regular training, experience, and practice to acquire and maintain.
The video laryngoscope (VL) is a recently developed device with a camera and light source on the tip of its blade that provides indirect glottic view. The Airtraq laryngoscope is a recently developed video laryngoscope. It has an anatomically shaped blade which contains two parallel channels, one, the guiding channel, for the insertion of the endotracheal tube (ETT) and the other, the optical channel, containing a series of lenses, prisms, and mirrors that transfer the image from the illuminated tip to a proximal viewfinder, giving a high-quality wide-angle view of the glottis and surrounding structures.
As compared to DL, Airtraq VL requires the application of lesser force to the base of the tongue and is thus less likely to stimulate stress response and induce local tissue injury, produces less cervical movement, and has a faster learning curve relative to DL. It has also been demonstrated to be beneficial in the difficult airway scenario, when compared with the Macintosh laryngoscope, by reducing the number of failed intubations, the duration of intubation attempts and the amount of airway manipulation required, making them suitable for use by medical personnel who intubate infrequently.
The purpose of this study is to evaluate learning and performance of tracheal intubation by first year anaesthesia trainee using either Airtraq VL or Macintosh laryngoscopes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- First year anaesthesia trainee are those residents in their first year of anaesthesia training and has not had any prior experience using either laryngoscope. They will be given adequate training and instructions before intubation on patients. On the day of surgery, the baseline airway variables and the baseline hemodynamic values will be recorded. An investigator not involved in assessing the patient outcome will open the sealed envelope according to the serial number of the patient enrolled into the study. Following standard induction technique of preoxygenation with 100% oxygen, injection fentanyl, injection propofol, injection veruronium and mixture of isoflurane and oxygen, tracheal intubation will then be performed by first year anaesthesia trainee using either Airtraq or Macintosh laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer.
| Arm | Type | Receives |
|---|---|---|
| Orotracheal intubation with macintosh laryngoscope | No intervention | –Following standard intubation protocol, tracheal intubation will be performed by first year anaesthesia trainee using Macintosh laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer on one group of patients. Duration of intubation attempt, failed intubation, optimization maneuvers required to perform tracheal intubation, glottic view according to the Cormack and Lehane grading will be evaluated. Similarly, the maximum fall in oxygen saturation during intubation, HR, SBP and DBP will be documented immediately following intubation and then every 5 minutes till the end of surgery. The occurrence of minor complications (visible trauma to lip or oral mucosa, and presence of blood on laryngoscope blade), and the postoperative sore throat and hoarseness will be evaluated at the end of surgery in the postoperative recovery room. |
| Orotracheal intubation with Airtraq Video Laryngoscope | Active comparator | Device: Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscopeFollowing standard intubation protocol, tracheal intubation will be performed by first year anaesthesia trainee using Airtraq video laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer on one group of patients. Duration of intubation attempt, failed intubation, optimization maneuvers required to perform tracheal intubation, glottic view according to the Cormack and Lehane grading will be evaluated. Similarly, the maximum fall in oxygen saturation during intubation, HR, SBP and DBP will be documented immediately following intubation and then every 5 minutes till the end of surgery. The occurrence of minor complications (visible trauma to lip or oral mucosa, and presence of blood on laryngoscope blade), and the postoperative sore throat and hoarseness will be evaluated at the end of surgery in the postoperative recovery room. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I and II
- Age group 16-65 years of either gender
- Patient requiring orotracheal intubation under general anaesthesia.
Key exclusion criteria (3 listed)
- Patient having respiratory tract (oropharynx, larynx) pathology,
- Patient with predicted difficult airway (such as mouth opening <2 cm),
- Patient having gastroesophageal reflux disease, hiatus hernia, and pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscopeTracheal intubation will be performed by first year anaesthesia trainee using either Macintosh laryngoscope or Airtraq video laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer on one group of patients. | Device | Orotracheal intubation with Airtraq Video Laryngoscope |
Primary outcome
Time required for tracheal intubation.
Time frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
Duration of intubation attempt will be defined as the time elapsed from insertion of the blade of laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords and confirmed by chest rise, auscultation, and square wave capnography
7 secondary outcomes
Intubation difficulty scale (IDS) score18 for each device.
Time frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
Rate of successful placement of endotracheal tube.
Time frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
Number of optimization maneuvers required to perform tracheal intubation.
Time frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
Changes in heart rate before and immediately following intubation.
Time frame: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
Incidence of trauma to the airway.
Time frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes
Changes in systolic, diastolic and mean blood pressure before and immediately following intubation
Time frame: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
Changes in oxygen saturation before and immediately following intubation
Time frame: From the randomization and before intubation to immediately following intubation and every 5 minutes till the end of surgery, upto 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- BackgroundRosenblatt WH, Sukhupragaran W. Airway management. In: Barash PG, Cullen BF, Stoelting RK, Cahalan MK, Stock MC, Ortega R, editors. Clinical Anesthesia. 7th ed. Philadelphia, PA: Wolters Kluwer Health/Lippincott Williams & Wilkins; 2013. p. 774.
- BackgroundBerry JM, Harvey S. Laryngoscopic Orotracheal and Nasotracheal Intubation. In: Benumof and Hagberg"s Airway Management; Hagberg CA, Gabel JC, editors, 3rd ed. Philadelphia, PA: Elsevier/Saunders; 2013. p.346-347.
- Results publicationZafirova Z, Tung A. The Difficult Airway: Definitions and Algorithms. In: Glick DB, Cooper RM, Ovassapian A, editors. The difficult airway. New York: Springer; 2013. p.1.
- Results publicationWoodall NM, Benger JR, Harper JS, et al. Airway management complications during anaesthesia, in intensive care units and in emergency departments in the UK. Trends in Anaesthesia and Critical Care. 2012; 2(2), 58-64. doi:10.1016/j.tacc.2012.02.005
- Results publication: PubMed 21550550Metzner J, Posner KL, Lam MS, Domino KB. Closed claims' analysis. Best Pract Res Clin Anaesthesiol. 2011 Jun;25(2):263-76. doi: 10.1016/j.bpa.2011.02.007.
- Results publication: PubMed 21447489Cook TM, Woodall N, Harper J, Benger J; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 2: intensive care and emergency departments. Br J Anaesth. 2011 May;106(5):632-42. doi: 10.1093/bja/aer059. Epub 2011 Mar 29.
- Results publication: PubMed 23242753Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012 Dec;109 Suppl 1:i68-i85. doi: 10.1093/bja/aes393.
- Results publicationMacintosh RR. A NEW LARYNGOSCOPE. The Lancet. 1943; 241(6233), 205.
- Results publicationMiller RA: A new laryngoscope. Anesthesiology. 1941, 2 (3): 310-316. 10.
- Results publication: PubMed 24741496Chemsian R, Bhananker S, Ramaiah R. Videolaryngoscopy. Int J Crit Illn Inj Sci. 2014 Jan;4(1):35-41. doi: 10.4103/2229-5151.128011.
- Results publication: PubMed 20887406Niforopoulou P, Pantazopoulos I, Demestiha T, Koudouna E, Xanthos T. Video-laryngoscopes in the adult airway management: a topical review of the literature. Acta Anaesthesiol Scand. 2010 Oct;54(9):1050-61. doi: 10.1111/j.1399-6576.2010.02285.x. Epub 2010 Jul 28.
- Results publication: PubMed 17585215Maharaj CH, Buckley E, Harte BH, Laffey JG. Endotracheal intubation in patients with cervical spine immobilization: a comparison of macintosh and airtraq laryngoscopes. Anesthesiology. 2007 Jul;107(1):53-9. doi: 10.1097/01.anes.0000267529.71756.f0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabin Bhandari, MD principal investigator
Assistant Professor, Department of Anaesthesiology and Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscope in people with Intubation; Difficult or Failed and Intubation Complication, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 3 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: status not confirmed, as of the sponsor's last update on 27 May 2020. 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 Nepal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabin Bhandari, MD (+977-9851161225, sabin7000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required for tracheal intubation. (time frame: From the time of randomization and insertion of the blade of the laryngoscope between the dental arches until the endotracheal tube is placed through the vocal cords upto start of surgery, assessed upto 15 minutes). 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 NCT04386356, which also lists 28 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 27 May 2020.