Head and Neck Position for Intubation Clinical Trial
Official title:
Optimal Head and Neck Position for Intubation During Videolaryngoscopy: Comparison Between "Sniffing" and Neutral Position Using Channelled and Non-channelled Videolaryngoscopes
| NCT number | NCT02558036 |
| Other study ID # | 178075 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 11, 2015 |
| Est. completion date | April 27, 2017 |
| Verified date | August 2018 |
| Source | University Hospitals Coventry and Warwickshire NHS Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Optimal patient head and neck position when performing videolaryngoscopy for endotracheal intubation has not yet been established.The investigators aim to assess the effect of two different positions on the laryngeal view obtained and success of tracheal intubation during videolaryngoscopy with two commercially available and well established videolaryngoscopes.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | April 27, 2017 |
| Est. primary completion date | April 27, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - All patients aged 18 and above, presenting for elective surgical procedure and requiring tracheal intubation will be invited to take part in the study. Exclusion Criteria: - Patients who are refusing to take part, below 18 years of age, pregnant women, American society of anaesthesiologists' class 4 and above, those requiring rapid sequence indication, super morbidly obese (BMI >50) and those patients requiring awake fibreoptic intubation will be excluded. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University Hospitals Coventry & Warwickshire NHS Trust | Coventry |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospitals Coventry and Warwickshire NHS Trust |
United Kingdom,
Adnet F, Baillard C, Borron SW, Denantes C, Lefebvre L, Galinski M, Martinez C, Cupa M, Lapostolle F. Randomized study comparing the "sniffing position" with simple head extension for laryngoscopic view in elective surgery patients. Anesthesiology. 2001 O — View Citation
Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7 — View Citation
Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. — View Citation
Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible — View Citation
El-Orbany M, Woehlck H, Salem MR. Head and neck position for direct laryngoscopy. Anesth Analg. 2011 Jul;113(1):103-9. doi: 10.1213/ANE.0b013e31821c7e9c. Epub 2011 May 19. Review. — View Citation
Greenland KB, Edwards MJ, Hutton NJ. External auditory meatus-sternal notch relationship in adults in the sniffing position: a magnetic resonance imaging study. Br J Anaesth. 2010 Feb;104(2):268-9. doi: 10.1093/bja/aep390. — View Citation
Serocki G, Neumann T, Scharf E, Dörges V, Cavus E. Indirect videolaryngoscopy with C-MAC D-Blade and GlideScope: a randomized, controlled comparison in patients with suspected difficult airways. Minerva Anestesiol. 2013 Feb;79(2):121-9. Epub 2012 Oct 2. — View Citation
Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Optimal Head and Neck Position during Videolaryngoscopy | This will be assessed using a Difficult Intubation Scale Score for each of the 2 videolaryngoscopes used in the study, which will be assessed in both neutral and sniffing positions. | 6 months | |
| Secondary | Laryngoscopy Time | From when the laryngoscope enters the mouth until achieving the best view of the larynx. | Less than 1 minute | |
| Secondary | Intubation Time | from entering the mouth with the videolaryngoscope until endotracheal tube is inserted in the wind-pipe and the capnography trace is first visible on the screen. | Less than 1 minute |