Hypoxia Clinical Trial
Official title:
Tematic Evaluation of a New Medical Device (STAIRWAY) for Open Airways
The goal of this four-part preclinical [I-II] and clinical [III-IV] trial is to compare, with randomised crossover study design [I-IV], a new medical airway device with standard procedure (biteblock or no device) for upper airway patency during sedation with intravenous propofol [I-IV]. - Page 1 of 9 [DRAFT] - The two main questions it aims to answer are if this new airway device is superior to standard procedure with respect to - maintenance of spontaneous ventilation [I] and upper airway volumes [II] at moderate and deep steady-state levels of sedation in healthy volunteer study participants, and - fewer and less lasting bedside signs of respiratory depression [III-IV], and less adjuvant use of manual airway support [III-IV] during procedural sedation (PS) according to standard of care(SOC) in study patients scheduled for colonoscopy or ureteral catheterisation under PS. Owing to the crossover study design used throughout the trial, there are no comparison groups of study participants [I-II] or study patients [III-IV].
Status | Not yet recruiting |
Enrollment | 56 |
Est. completion date | January 2024 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | INCLUSION CRITERIA Parts I-II: Adult. No known allergy or hypersensitivity to drugs used for routine sedation or to ID materials (polypropylene or ethylene vinylacetate). Healthy with no medical comorbidity according to physician's judgement and physical examination. No cognitive or psychosocial distress. Complete or partial dentation. No mobile teeth or reconstructions. No orthodontic braces. Non-pregnant. Not breastfeeding. Ability to communicate in Swedish. No in situ magnetic device or implant [II]. Oral and written informed consent to inclusion as healthy volunteer study participant. Parts III-IV: Adult scheduled for elective colonoscopy [III] or ureteral catheterisation [IV] under procedural sedation with propofol. No known allergy or hypersensitivity to drugs used for routine sedation or to ID materials (polypropylene or ethylene vinylacetate) in the ID. Comorbidity ASA class I-III. No cognitive or psychosocial distress. Complete or partial dentation. No mobile teeth or reconstructions. No orthodontic braces. Non-pregnant. Not breastfeeding. Ability to communicate in Swedish. Oral and written informed consent to inclusion as study participant. EXCLUSION CRITERIA Parts I-IV: Withdrawal of informed consent. Suspected or manifest unforeseen allergic reaction. Inability to obtain enough relevant study data for medical or technical reasons. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Stairway Medical AB | Lund University, Skane University Hospital |
Amornyotin S, Aanpreung P, Prakarnrattana U, Chalayonnavin W, Chatchawankitkul S, Srikureja W. Experience of intravenous sedation for pediatric gastrointestinal endoscopy in a large tertiary referral center in a developing country. Paediatr Anaesth. 2009 Aug;19(8):784-91. doi: 10.1111/j.1460-9592.2009.03063.x. — View Citation
Ciscar MA, Juan G, Martinez V, Ramon M, Lloret T, Minguez J, Armengot M, Marin J, Basterra J. Magnetic resonance imaging of the pharynx in OSA patients and healthy subjects. Eur Respir J. 2001 Jan;17(1):79-86. doi: 10.1183/09031936.01.17100790. — View Citation
Cravero JP, Beach ML, Blike GT, Gallagher SM, Hertzog JH; Pediatric Sedation Research Consortium. The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium. Anesth Analg. 2009 Mar;108(3):795-804. doi: 10.1213/ane.0b013e31818fc334. — View Citation
Eastwood PR, Szollosi I, Platt PR, Hillman DR. Collapsibility of the upper airway during anesthesia with isoflurane. Anesthesiology. 2002 Oct;97(4):786-93. doi: 10.1097/00000542-200210000-00007. — View Citation
Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for — View Citation
Mellin-Olsen J, Staender S. The Helsinki Declaration on Patient Safety in Anaesthesiology: the past, present and future. Curr Opin Anaesthesiol. 2014 Dec;27(6):630-4. doi: 10.1097/ACO.0000000000000131. — View Citation
Muller M, Wehrmann T, Eckardt AJ. Prospective evaluation of the routine use of a nasopharyngeal airway (Wendl Tube) during endoscopic propofol-based sedation. Digestion. 2014;89(4):247-52. doi: 10.1159/000360000. Epub 2014 Jun 4. — View Citation
Roh WS, Kim DK, Jeon YH, Kim SH, Lee SC, Ko YK, Lee YC, Lee GH. Analysis of anesthesia-related medical disputes in the 2009-2014 period using the Korean Society of Anesthesiologists database. J Korean Med Sci. 2015 Feb;30(2):207-13. doi: 10.3346/jkms.2015.30.2.207. Epub 2015 Jan 21. — View Citation
van Schaik EPC, Blankman P, Van Klei WA, Knape HJTA, Vaessen PHHB, Braithwaite SA, van Wolfswinkel L, Schellekens WM. Hypoxemia during procedural sedation in adult patients: a retrospective observational study. Can J Anaesth. 2021 Sep;68(9):1349-1357. doi: 10.1007/s12630-021-01992-6. Epub 2021 Apr 20. — View Citation
Youn AM, Ko YK, Kim YH. Anesthesia and sedation outside of the operating room. Korean J Anesthesiol. 2015 Aug;68(4):323-31. doi: 10.4097/kjae.2015.68.4.323. Epub 2015 Jul 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in absolute and relative tidal volumes at deep sedation [I] | Nonblinded intra-individual randomised crossover evaluation, in a semi-closed-loop breathing system, of absolute (mL) and relative (mL/kg bodyweight) tidal volumes at deep steady-state level of propofol sedation between use of ID versus biteblock in supine spontaneously breathing adult volunteer study participants. | Estimated duration of measurements: 2-3 minutes per intervention. Estimated study period: 1-2 hours per participant. | |
Primary | Difference in absolute and relative MRI-derived anteroposterior transpharyngeal distances at deep sedation [II] | Nonblinded intra-individual randomised crossover evaluation, in an open breathing system, of absolute (mm) and relative (mm/kg bodyweight) anteroposterior transpharyngeal distances determined by MRI at deep steady-state level of propofol sedation between use of ID versus biteblock and versus no device in supine spontaneously breathing adult volunteer study participants. | Estimated duration of measurements: 2-3 min per intervention. Estimated study period: 1.5-2.5 h per participant. | |
Primary | Difference in adjuvant use of manual airway support during PS according to SOC [III-IV]. | Nonblinded intra-individual randomised crossover evaluation, in an open breathing system, of cumulative adjuvant use of manual airway support (seconds per minute) during PS with propofol according to SOC between use in spontaneously breathing adult volunteer study participants of ID versus no device in various body positions (as required by the interventional procedure) [III], or in supine body position [IV]. | Duration of measurements: 8 minutes per intervention. Estimated study period: 0.5-1 hours per patient.] | |
Secondary | Difference in absolute and relative tidal volumes at light and moderate sedation [I] | Nonblinded intra-individual randomised crossover evaluation, in a semi-closed-loop breathing system, of absolute (mL) and relative (mL/kg bodyweight) tidal volumes at moderate and at light steady-state levels of propofol sedation between use of ID versus biteblock in supine spontaneously breathing adult volunteer study participants. | Estimated duration of measurements: 2-3 minutes per intervention. Estimated study period: 1-2 hours per participant. | |
Secondary | Difference in duration (seconds) of maintained ETCO2 recording without sedation [I]. | Nonblinded itra-individual randomised crossover evaluation, in an open breathing system, of duration (seconds per minute) of maintained ETCO2 recording at defined levels of O2 supply (1-2-3-5 L/min) between ID versus nasal cannula in supine spontaneously breathing awake adult volunteer study participants. | Estimated duration of measurements: 2-3 min per intervention. Estimated study period: 1-2 h per participant. | |
Secondary | Difference in duration (seconds per minute) of hypoxia (SpO2 <95 %) during PS according to SOC [III-IV]. | Nonblinded intra-individual randomised crossover evaluation, in an open breathing system, of duration (seconds per minute) of at least mild hypoxia (SpO2 <95 %) during PS according to SOC between ID versus no device in supine spontaneously breathing adult study patients. | Duration of measurements: 8 minutes per intervention. Estimated study period: 0.5-1 hours per patient. | |
Secondary | Perceived sedational comfort [I-IV] and individual preference [III-IV] by study participants. | Nonblinded survey evaluation of perceived sedational comfort (VAS units) with ID in adult volunteer study participants subjected to light, moderate and deep steady-state levels of sedation [I-II], and in adult study patients subjected to PS according to SOC [III-IV], and of preference between ID and no device by adult study patients subjected to PS according to SOC [III-IV]. | Estimated duration of data achievement: 3-4 minutes. Estimated study period: 0.5-2.5 hours per participant [I-IV]. | |
Secondary | Perceived usability and individual preference by study sedationists [III-IV]. | Nonblinded individual survey evaluation in study sedationists of perceived usability of ID (preparation, induction, maintenance and emergence; VAS-units), and of individual preference, of ID versus no device, for PS according to SOC in adult study patients scheduled for elective colonoscopy [III] or ureteral catheterisation [IV]. | Estimated duration of data achievement: 3-4 minutes. Estimated study period: 0.5-2.5 hours per participant [I-IV]. | |
Secondary | Perceived procedural feasibility and individual preference by procedural interventionists [III-IV]. | Blinded individual survey evaluation in procedural interventionists of perceived procedural feasability of first versus second study intervention (ID or no device), and of individual preference, of first versus second study intervention, during PS according to SOC in adult study patients scheduled for elective colonoscopy [III] or ureteral catheterisation [IV]. | Estimated duration of data achievement: 3-4 minutes. Estimated study period: 0.5-2.5 hours per participant [I-IV]. |
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