Evaluation of Medical Device for Airway Patency During Sedation (SW01-2022)

NCT05708651 | Unknown DMC

• 2 other identifiers: CIV-22-09-040787Dnr: 5.1-2022-75020
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 \[III-IV\].

Conditions

Airway Obstruction; Sedation Complication; Safety Issues; Patient Satisfaction; Work Related Stress; Breathing Arrested; Complication of Treatment; Hypoxia

Keywords

Sedation, procedural; Airway patency; Device, medical; Patient safety; Respiratory depression; Breathing, spontaneous; Propofol; Sedation, level; Biteblock

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (6)

• Difference in absolute and relative tidal volumes at light and moderate sedation [I]

  Estimated duration of measurements: 2-3 minutes per intervention. Estimated study period: 1-2 hours per participant.

• Difference in duration (seconds) of maintained ETCO2 recording without sedation [I].

  Estimated duration of measurements: 2-3 min per intervention. Estimated study period: 1-2 h per participant.

• Difference in duration (seconds per minute) of hypoxia (SpO2 <95 %) during PS according to SOC [III-IV].

  Duration of measurements: 8 minutes per intervention. Estimated study period: 0.5-1 hours per patient.

• Perceived sedational comfort [I-IV] and individual preference [III-IV] by study participants.

  Estimated duration of data achievement: 3-4 minutes. Estimated study period: 0.5-2.5 hours per participant [I-IV].

• Perceived usability and individual preference by study sedationists [III-IV].

  Estimated duration of data achievement: 3-4 minutes. Estimated study period: 0.5-2.5 hours per participant [I-IV].

Study Arms (2)

Use of investigational device during sedation

EXPERIMENTAL

Intra-individual randomised paired crossover evaluation of airway patency with investigational device in volunteer study participants \[I-II\] and study patients \[III-IV\] at low, moderate and deep levels of steady-state sedation \[I-II\], and during procedural sedation according to SOC for scheduled colonoscopy \[III\] or ureteral catheterisation \[IV\].

Device: Investigational device [I-IV]

Use of comparator during sedation

ACTIVE COMPARATOR

Intra-individual randomised paired crossover evaluation of airway patency with comparator (biteblock \[I-II\] or no device \[II-IV\]) in volunteer study participants \[I-II\] and study patients \[III-IV\] at low, moderate and deep levels of steady-state sedation \[I-II\], and during procedural sedation according to SOC for scheduled colonoscopy \[III\] or ureteral catheterisation \[IV\].

Device: Comparator [I-IV]

Interventions

Investigational device [I-IV] DEVICE

Intra-individual randomised paired crossover evaluation of airway patency with investigational device in volunteer study participants \[I-II\] and study patients \[III-IV\] at low, moderate and deep steady-state sedation \[I-II\] or procedural sedation according to SOC \[III-IV\].

Use of investigational device during sedation

Comparator [I-IV] DEVICE

Intra-individual randomised paired crossover evaluation of airway patency with comparator (biteblock \[I-II\] or no device \[II-IV\]) in volunteer study participants \[I-II\] and study patients \[III-IV\] at low, moderate and deep levels of steady-state sedation \[I-II\], and during procedural sedation according to SOC for scheduled colonoscopy \[III\] or ureteral catheterization \[IV\].

Also known as: • Biteblock [I-II] • No device [II-IV]

Use of comparator during sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[II\].
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stairway Medical AB: lead
• Lund University: collaborator
• Skane University Hospital: collaborator

Related Publications (10)

• 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.

  PMID: 25254572 BACKGROUND

• 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.

  PMID: 33880728 BACKGROUND

• 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.

  PMID: 11307760 BACKGROUND

• 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.

  PMID: 26257843 BACKGROUND

• 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.

  PMID: 25653494 BACKGROUND

• 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.

  PMID: 24903468 BACKGROUND

• 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.

  PMID: 19624366 BACKGROUND

• 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.

  PMID: 19224786 BACKGROUND

• 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.

  PMID: 12357141 BACKGROUND

• 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 procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.

  PMID: 28877145 RESULT

MeSH Terms

Conditions

Airway Obstruction; Patient Satisfaction; Occupational Stress; Apnea; Hypoxia; Respiratory Insufficiency; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Jonas Åkeson, Professor

  Lund University; Region Skane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Åkeson, Professor

CONTACT

+46708311113; jonas.akeson@med.lu.se

Thomas List, Professor

CONTACT

+46722181575; thomas.list@mau.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All study data recorded on-site will be masked for investigational device or comparator (and recorded in individually randomized order) in the study protocols. For practical reasons, study participants, care providers and on-site investigators cannot be masked for investigational device versus comparator.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Four-part preclinical \[I-II\] and clinical \[III-IV\] trial carried out, in 12 + 12 volunteer study participants \[I-II\] and in 16 + 16 study patients \[III-IV)\], according to an intra-individual randomised paired crossover study design, where the investigational device is compared with standard procedure (comparator; biteblock \[I-II\] or no device \[II-IV\]) for airway patency (tidal volume \[I\], transpharyngeal distance \[II\], signs of airway obstruction \[III-IV\], use of manual airway support \[III-IV\]).

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: February 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share