Medical Device for Airway Patency During Sedation

NCT06270212 | Unknown DMC

• 1 other identifier: CIV-ID 23-08-043797
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

OVERALL SYNOPSIS PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants

• of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype (STAIRWAY) vs. standard procedure (no device) during target-controlled induction of mild and moderate-to-deep sedation with propofol in the supine position
• of minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels, determined by magnetic resonance imaging (MRI) with STAIRWAY vs. biteblock or no device during no, mild and moderate-to-deep steady-state sedation with propofol in the supine position. PART B: Systematic evaluation (in the body position \[normally supine\] considered most optimal for the procedural intervention) of the cumulative duration
• of adjuvant manual airway support and ventilation
• of respiratory arrest (interrupted monitoring of endtidal carbon dioxide \[ETCO2\])
• of hypoxemia (hemoglobin saturation of oxygen \[SpO2\] \<95 %), and
• of perceived sedational comfort, of sedational and procedural usability, and of sedational and procedural preference with STAIRWAY vs. standard procedure (biteblock or no device) during PS according to SOC for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in spontaneously breathing study patients.

Conditions

Airway Obstruction; Sedation Complication; Perioperative Complication

Keywords

Airway; Device; Hypoxemia; Propofol; Respiration; Sedation

Outcome Measures

Primary Outcomes (2)

• Transpharyngeal distance during moderate-to-deep steady-state sedation.

  Differences in minimum anteroposterior and lateral transpharyngeal distances (mm) at tongue-base and soft-palate levels, determined by an experienced radiologist with specific MRI competence, based on MRI scans obtained with a General Electric SIGNA™ Architect 3T MRI scanner, between use of STAIRWAY vs. NO DEVICE during moderate-to-deep (OAA/S level 2-3) steady-state sedation with propofol \[PART A\].

  Five months

• Duration of manual airway support during PS for clinical procedures.

  Difference in cumulative duration (s) of adjuvant manual measures for airway support between use of STAIRWAY vs. NO DEVICE during procedural sedation with propofol according to standard of care for scheduled diagnostic or therapeutic procedures planned to be carried out under procedural sedation with propofol \[PART B\].

  Six months

Secondary Outcomes (6)

• Transpharyngeal distance during mild steady-state sedation.

  Five months

• Duration of interrupted capnometric monitoring during sedation.

  Six months

• Duration of manual airway support during induction of steady-state sedation.

  Five months

• Sedational comfort

  Six months

• Conditions for sedation

  Six months

Study Arms (2)

STAIRWAY

ACTIVE COMPARATOR

Unpaired evaluation of STAIRWAY during induction of steady-state sedation in volunteer study participants (PART A), and during induction and maintenance of PS according to SOC in study patients (PART B).

Device: STAIRWAY

NO DEVICE

OTHER

Unpaired evaluation of NO DEVICE during induction of steady-state sedation in volunteer study participants (PART A), and during induction and maintenance of PS according to SOC in study patients (PART B).

Device: NO DEVICE

Interventions

STAIRWAY DEVICE

Evaluation of STAIRWAY (new airway device) during sedation.

STAIRWAY

NO DEVICE DEVICE

Evaluation of NO DEVICE during sedation

NO DEVICE

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• PARTS A-B: Withdrawal of informed consent. Suspected or manifest unforeseen severe allergic reaction. Inability to obtain enough useful study data for practical or medicotechnical reasons.

Sponsors & Collaborators

• Stairway Medical AB: lead
• Lund University: collaborator

Study Sites (1)

Skåne University Hospital

Malmo, Skåne County, 20502, Sweden

RECRUITING

MeSH Terms

Conditions

Airway Obstruction; Hypoxia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Jonas Åkeson, Professor

  Lund University, Malmö, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Åkeson, Professor

CONTACT

0708311113; jonas.akeson@med.lu.se

Magnus Ljungvall, Consultant

CONTACT

0705445502; magnus.ljungvall@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For practical reasons, study participants, sedationists and study investigators on site cannot be masked to study interventions. However, procedural interventionists on site and study investigators scrutinizing study outcome data will be masked to study interventions. The number of enrolled study participants reported below (46) refers to evaluable ones.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective randomized unpaired, and paired crossover, evaluations of study outcome measures in healthy volunteer study participants (PART A), and prospective randomized unpaired evaluation of study outcome measures in study patients (PART B). The number of arms reported below (3) refers to unpaired comparisons (PARTS A-B).

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 21, 2024
• Study Start: February 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 21, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)