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

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

Interventions

DEVICE

Investigational device [I-IV]

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 \[III-IV\].

DEVICE

Comparator [I-IV]

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 \[IV\].

Sponsors & Collaborators

• Lund University

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Stairway Medical AB

  lead INDUSTRY

Principal Investigators

• Jonas Åkeson, Professor · Lund University; Region Skane

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-28

Primary Completion

2023-06-30

Completion

2024-01-31