- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02934347
Comparison of Glottic Views and Intubation Times in the Supine and 25 Degree Back-up Positions
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
The sniffing position has traditionally been considered the optimal head position for direct laryngoscopy and is the usual patient position preferred by most anaesthetists. In theory, neck flexion aligns the pharyngeal and laryngeal axes, and head extension at the atlanto-occipital joint aligns the oral axis with these two axes allowing the line of sight to fall on the glottis. It is recognized as the starting head position for direct laryngoscopy because it provides the best chance of adequate exposure.
However the sniffing position does not guarantee adequate exposure in all patients because many other anatomical factors control the final degree of visualization.
To achieve a proper sniffing position in obese patients, the "ramped" (or the back-up) position has been used as this produces better neck flexion and head extension in these patients when compared to the horizontal supine position. Also the forces required to elevate and move the tongue and other tissues out of the line of sight are less when the patients are ramped.
Our hypothesis is that the view of the glottis may be improved by putting all (ie not only obese) patients requiring intubation in the ramped or back up position while maintaining the classic sniffing position.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- Adult surgical patients who required intubation as part of their routine anaesthesia
Exclusion Criteria:
- Patients less than 18 years old,
- Patients recognised to have difficult airways where an alternative method of intubation (e.g. fibre optic) was the method of choice,
- Patients undergoing emergency surgery where patient positioning and data collection might cause delay (e.g. exsanguinating patients) or where the supine position is not optimal (e.g. brisk bleeding into the upper airway),
- Patients requiring rapid sequence induction of anaesthesia
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
---|---|
Supine
A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
|
|
Back-up
A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
|
To test whether a 25 degree back-up position improves laryngeal views and makes intubation easier compared to the standard horizontal position
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
The Best Glottic View Obtained During Laryngoscopy
Aikaikkuna: The view of the glottis was measured once while the patient was being intubated
|
The best glottic view obtained during laryngoscopy was assessed using the Cormack and Lehane classification by the anaesthetist performing the laryngoscopy. The Cormack and Lehane classifies glottic views as follows: Grade 1: Most of the glottis is visible, Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen., Grade 3: Only the epiglottis is visible, Grade 4: No laryngeal structures are visible. |
The view of the glottis was measured once while the patient was being intubated
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
The Number of Attempts at Both Laryngoscopy and Tracheal Intubation
Aikaikkuna: Once at intubation
|
The number of attempts at both laryngoscopy and tracheal intubation were recorded
|
Once at intubation
|
The Use of Ancillary Equipment
Aikaikkuna: Once at intubation
|
The use of ancillary equipment (e.g.
bougie, alternative laryngoscope blades) and manoeuvres (e.g.
laryngeal manipulation) were recorded but applied at the intubating anaesthetist's discretion
|
Once at intubation
|
The Time Between the Beginning of Laryngoscopy and Detection of Carbon Dioxide on the End-tidal Carbon Dioxide Monitor
Aikaikkuna: Once at intubation
|
The time between the beginning of laryngoscopy and detection of carbon dioxide on the end-tidal carbon dioxide monitor after the successful placement of the tracheal tube was recorded
|
Once at intubation
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Raj M Reddy, FRCA, Anaesthetic Department, Glan Clwyd Hospital, Betsi Cadwaladr University Health Board
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Dixon BJ, Dixon JB, Carden JR, Burn AJ, Schachter LM, Playfair JM, Laurie CP, O'Brien PE. Preoxygenation is more effective in the 25 degrees head-up position than in the supine position in severely obese patients: a randomized controlled study. Anesthesiology. 2005 Jun;102(6):1110-5; discussion 5A. doi: 10.1097/00000542-200506000-00009.
- Lane S, Saunders D, Schofield A, Padmanabhan R, Hildreth A, Laws D. A prospective, randomised controlled trial comparing the efficacy of pre-oxygenation in the 20 degrees head-up vs supine position. Anaesthesia. 2005 Nov;60(11):1064-7. doi: 10.1111/j.1365-2044.2005.04374.x.
- 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. doi: 10.1381/0960892042386869.
- Greenland KB, Edwards MJ, Hutton NJ, Challis VJ, Irwin MG, Sleigh JW. Changes in airway configuration with different head and neck positions using magnetic resonance imaging of normal airways: a new concept with possible clinical applications. Br J Anaesth. 2010 Nov;105(5):683-90. doi: 10.1093/bja/aeq239. Epub 2010 Sep 15.
- Lee BJ, Kang JM, Kim DO. Laryngeal exposure during laryngoscopy is better in the 25 degrees back-up position than in the supine position. Br J Anaesth. 2007 Oct;99(4):581-6. doi: 10.1093/bja/aem095. Epub 2007 Jul 4.
- 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 Oct;95(4):836-41. doi: 10.1097/00000542-200110000-00009.
- Bannister FB, Macbeth RG. Direct laryngoscopy and tracheal intubation. Lancet 1944; 2: 651-4
- Jackson C. Bronchoscopy and Esophagoscopy: A Manual of Peroral Endoscopy and Laryngeal Surgery. Philadelphia and London: WB Saunders; 1922
- Lee HC, Yun MJ, Hwang JW, Na HS, Kim DH, Park JY. Higher operating tables provide better laryngeal views for tracheal intubation. Br J Anaesth. 2014 Apr;112(4):749-55. doi: 10.1093/bja/aet428. Epub 2013 Dec 18.
- Rao SL, Kunselman AR, Schuler HG, DesHarnais S. Laryngoscopy and tracheal intubation in the head-elevated position in obese patients: a randomized, controlled, equivalence trial. Anesth Analg. 2008 Dec;107(6):1912-8. doi: 10.1213/ane.0b013e31818556ed.
- Lebowitz PW, Shay H, Straker T, Rubin D, Bodner S. Shoulder and head elevation improves laryngoscopic view for tracheal intubation in nonobese as well as obese individuals. J Clin Anesth. 2012 Mar;24(2):104-8. doi: 10.1016/j.jclinane.2011.06.015. Epub 2012 Feb 1.
- Reddy RM, Adke M, Patil P, Kosheleva I, Ridley S; Anaesthetic Department at Glan Clwyd Hospital. Comparison of glottic views and intubation times in the supine and 25 degree back-up positions. BMC Anesthesiol. 2016 Nov 16;16(1):113. doi: 10.1186/s12871-016-0280-4.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muut tutkimustunnusnumerot
- BetsiCUHB
Yksittäisten osallistujien tietojen suunnitelma (IPD)
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IPD-suunnitelman kuvaus
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