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Medical Device for Airway Patency During Sedation

NCT06270212 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-02-21

No results posted yet for this study

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

Interventions

DEVICE

STAIRWAY

Evaluation of STAIRWAY (new airway device) during sedation.

DEVICE

NO DEVICE

Evaluation of NO DEVICE during sedation

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Stairway Medical AB

    lead INDUSTRY

Principal Investigators

  • Jonas Åkeson, Professor · Lund University, Malmö, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270212 on ClinicalTrials.gov