Airway ObstructionSTAIRWAY-2NCT06270212
Medical Device for Airway Patency During Sedation
A study testing STAIRWAY and NO DEVICE in people with Airway Obstruction and Sedation Complication, run by Stairway Medical AB at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Obstruction, Sedation Complication, Perioperative Complication
- What is being tested?
- STAIRWAY and NO DEVICE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PART A: Adult (18-65 years). No known allergy or hypersensitivity to drugs used for routine sedation or to materials (PP or EVA) comprising STAIRWAY. Medically healthy with no comorbidity according to careful investigation by senior anaesthesiologist in charge of the sedation. No in situ magnetic device or implant. No cognitive or psychosocial distress, particularly including claustrofobia. Complete dentation. No mobile teeth, mobile reconstructions or orthodontic braces. Non-pregnant. No ongoing breast-feeding. Ability to communicate in Swedish. Oral and written informed consent to inclusion as healthy volunteer study participant.
- PART B: Adult (18 years and above) scheduled for elective diagnostic or therapeutic procedures under PS with propofol. No known allergy or hypersensitivity to drugs used for PS or to materials (PP or EVA) comprising STAIRWAY. Medical comorbidity corresponding to ASA class I-III. No cognitive or psychosocial distress. Complete or partial dentation. No mobile teeth, mobile reconstructions or orthodontic braces. Ability to communicate in Swedish. Oral and written informed consent to inclusion as study participant.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Malmö, Skåne County, 20502
Magnus Ljungvall, MD, +46-705445502, magnus.ljungvall@med.lu.se
Jonas Åkeson, PhD, Professor, +46-708311113, jonas.akeson@med.lu.se
About this study
Official title: Complementary Systematic Evaluation of a New Medical Device (STAIRWAY) for Open Airways During Sedation
OVERALL SYNOPSIS
PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants
Read more
- 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.
Read the detailed description
NUMBERS OF STUDY PARTICIPANTS
PART A: 12 (6 female) evaluable study participants (adult healthy volunteers).
PART B: 34 evaluable study participants (adult patients).
DURATION OF INVESTIGATION FOR COLLECTION OF STUDY DATA
PART A: Two months (February until March 2024).
PART B: Six months (February until July 2024).
STUDY FOLLOW-UP
PART A: Short-term questionnaire-based follow-up by individual study participants' survey at study site immediately after appropriate awakening from, and completed collection of study data during, mild and moderate-to-deep steady-state sedation.
PART B: Short-term questionnaire-based follow-up by individual study patients', sedationists' and procedural interventionists' surveys at the study site immediately after appropriate awakening from, and completed collection of study data during, PS according to SOC.
PRIMARY STUDY OBJECTIVES
PART A: Randomized paired crossover comparison of MRI-derived minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels during spontaneous breathing of pure oxygen at mild (Observer Assessment of Alertness/Sedation [OAA/S] level 4) and moderate-to-deep (OAA/S level 2-3) sedation - assessed by estimated target organ levels of propofol according to computerized infusion pump settings, and by bedside judgements of OAA/S levels - in the supine body position with STAIRWAY vs. standard procedure (biteblock or no device).
PART B: Randomized unpaired comparison (by continuous systematic observation and recording) of cumulative duration of adjuvant use of manual airway support and ventilation with STAIRWAY vs. standard procedure (no device) during PS according to SOC - assessed by estimated target tissue levels of propofol according to computerized infusion pump settings, by clinical bedside judgements of sedation levels according to OAA/S, and by monitored Bispectral Index Score (BIS) levels - for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in the body position (normally supine) most optimal for the procedure.
SECONDARY STUDY OBJECTIVES
PART A: Randomized unpaired comparison of cumulative duration of interrupted ETCO2 monitoring, of SpO2 <95 %, and of adjuvant manual airway measures and mask ventilation, with STAIRWAY vs. no device during computerized target-controlled intravenous (iv) infusion (TCI) of propofol to attain mild and moderate-to-deep steady-state levels of sedation. Individual questionnaire-based evaluation of perceived sedational comfort (VAS units).
PART B: Randomized unpaired comparison of incidence and cumulative duration of interrupted ETCO2 monitoring, and of SpO2 <95 %, during PS according to SOC - assessed by algorithm-based estimated target organ levels of propofol, and by clinical bedside judgements of sedation levels according to OAA/S - for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in the body position (normally supine) most optimal for the procedure with STAIRWAY vs. no device (standard procedure). Individual questionnaire-based evaluation of perceived sedational comfort (VAS units) by unblinded study patients, of perceived sedational usability (VAS units) by unblinded sedationists, and of perceived procedural conditions (VAS units) by blinded interventionists, soon after completion of PS according to SOC with STAIRWAY or no device.
- Being tested
- STAIRWAY, NO DEVICE
- Keywords
- Airway, Device, Hypoxemia, Propofol, Respiration, Sedation
- Medical subject headings
- Airway Obstruction, Hypoxia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAIRWAYDevice
Evaluation of STAIRWAY (new airway device) during sedation.
NO DEVICEDevice
Evaluation of NO DEVICE during sedation
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: NO DEVICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: 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].
Measured: Six months
Secondary outcomes (6)
Transpharyngeal distance during mild 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, at tongue-base and soft-palate levels, between use of STAIRWAY vs. NO DEVICE during mild (OAA/S level 4) steady-state sedation with propofol [PART A].
Measured: Five months
Duration of interrupted capnometric monitoring during sedation.
Differences in cumulative duration (s) of interrupted ETCO2 monitoring between STAIRWAY vs. NO DEVICE during induction of mild and moderate-to-deep levels of sedation (Philips Expression MR400 monitor) with propofol [PART A], and during induction and maintenance of procedural sedation with propofol according to standard of care (Philips MX800 monitor) for scheduled diagnostic or therapeutic procedures planned to be carried out under procedural sedation with propofol [PART B].
Measured: Six months
Duration of manual airway support during induction of steady-state sedation.
Differences in cumulative duration (s) of manual measures for adjuvant airway support between STAIRWAY vs. NO DEVICE during induction of mild and moderate-to-deep steady-state sedation with propofol [PART A].
Measured: Five months
Sedational comfort
Perceived sedational comfort, individually assessed by study participants between 0.0 (minimum score) and 10.0 (maximum score) on a 100 mm visual analogue score line, with STAIRWAY or NO DEVICE, after induction of mild and moderate-to-deep steady-state sedation with propofol [PART A], and after 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].
Measured: Six months
Conditions for sedation
Perceived conditions for sedation, individually assessed by sedationists between 0.0 (minimum score) and 10.0 (maximum score) on a 100 mm visual analogue score line, and individual preference, with STAIRWAY or NO DEVICE, after 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].
Measured: Six months
Conditions for procedural intervention
Perceived conditions for procedural intervention, individually assessed by interventionists/surgeons between 0.0 (minimum score) and 10.0 (maximum score) on a 100 mm visual analogue score line, and individual preference, with STAIRWAY or NO DEVICE, after 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].
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Feb 2024
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stairway Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Jonas Åkeson, Professor, Principal investigator, Lund University, Malmö, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270212
- Sponsor's protocol ID
- CIV-ID 23-08-043797
- Acronym
- STAIRWAY-2
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Systematic Evaluation of a New Medical Device (STAIRWAY) for Open Airways During Sedation
- ClinicalTrials.gov ID
- NCT06270212
- Acronym / sponsor ID
- STAIRWAY-2 / CIV-ID 23-08-043797
- Keywords
- Airway, Device, Hypoxemia, Propofol, Respiration, Sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Stairway Medical ABIndustry (pharma, biotech, devices)
- Collaborators
- Lund University
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
NUMBERS OF STUDY PARTICIPANTS
PART A: 12 (6 female) evaluable study participants (adult healthy volunteers).
PART B: 34 evaluable study participants (adult patients).
DURATION OF INVESTIGATION FOR COLLECTION OF STUDY DATA
PART A: Two months (February until March 2024).
PART B: Six months (February until July 2024).
STUDY FOLLOW-UP
PART A: Short-term questionnaire-based follow-up by individual study participants' survey at study site immediately after appropriate awakening from, and completed collection of study data during, mild and moderate-to-deep steady-state sedation.
PART B: Short-term questionnaire-based follow-up by individual study patients', sedationists' and procedural interventionists' surveys at the study site immediately after appropriate awakening from, and completed collection of study data during, PS according to SOC.
PRIMARY STUDY OBJECTIVES
PART A: Randomized paired crossover comparison of MRI-derived minimum anteroposterior and lateral transpharyngeal distances at tongue-base and soft-palate levels during spontaneous breathing of pure oxygen at mild (Observer Assessment of Alertness/Sedation [OAA/S] level 4) and moderate-to-deep (OAA/S level 2-3) sedation - assessed by estimated target organ levels of propofol according to computerized infusion pump settings, and by bedside judgements of OAA/S levels - in the supine body position with STAIRWAY vs. standard procedure (biteblock or no device).
PART B: Randomized unpaired comparison (by continuous systematic observation and recording) of cumulative duration of adjuvant use of manual airway support and ventilation with STAIRWAY vs. standard procedure (no device) during PS according to SOC - assessed by estimated target tissue levels of propofol according to computerized infusion pump settings, by clinical bedside judgements of sedation levels according to OAA/S, and by monitored Bispectral Index Score (BIS) levels - for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in the body position (normally supine) most optimal for the procedure.
SECONDARY STUDY OBJECTIVES
PART A: Randomized unpaired comparison of cumulative duration of interrupted ETCO2 monitoring, of SpO2 <95 %, and of adjuvant manual airway measures and mask ventilation, with STAIRWAY vs. no device during computerized target-controlled intravenous (iv) infusion (TCI) of propofol to attain mild and moderate-to-deep steady-state levels of sedation. Individual questionnaire-based evaluation of perceived sedational comfort (VAS units).
PART B: Randomized unpaired comparison of incidence and cumulative duration of interrupted ETCO2 monitoring, and of SpO2 <95 %, during PS according to SOC - assessed by algorithm-based estimated target organ levels of propofol, and by clinical bedside judgements of sedation levels according to OAA/S - for scheduled diagnostic or therapeutic procedures planned to be carried out under PS with propofol in the body position (normally supine) most optimal for the procedure with STAIRWAY vs. no device (standard procedure). Individual questionnaire-based evaluation of perceived sedational comfort (VAS units) by unblinded study patients, of perceived sedational usability (VAS units) by unblinded sedationists, and of perceived procedural conditions (VAS units) by blinded interventionists, soon after completion of PS according to SOC with STAIRWAY or no device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| STAIRWAY | Active comparator | Device: STAIRWAYUnpaired 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). |
| NO DEVICE | Other | Device: NO DEVICEUnpaired 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- PART A: Adult (18-65 years). No known allergy or hypersensitivity to drugs used for routine sedation or to materials (PP or EVA) comprising STAIRWAY. Medically healthy with no comorbidity according to careful investigation by senior anaesthesiologist in charge of the sedation. No in situ magnetic device or implant. No cognitive or psychosocial distress, particularly including claustrofobia. Complete dentation. No mobile teeth, mobile reconstructions or orthodontic braces. Non-pregnant. No ongoing breast-feeding. Ability to communicate in Swedish. Oral and written informed consent to inclusion as healthy volunteer study participant.
- PART B: Adult (18 years and above) scheduled for elective diagnostic or therapeutic procedures under PS with propofol. No known allergy or hypersensitivity to drugs used for PS or to materials (PP or EVA) comprising STAIRWAY. Medical comorbidity corresponding to ASA class I-III. No cognitive or psychosocial distress. Complete or partial dentation. No mobile teeth, mobile reconstructions or orthodontic braces. Ability to communicate in Swedish. Oral and written informed consent to inclusion as study participant.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAIRWAYEvaluation of STAIRWAY (new airway device) during sedation. | Device | STAIRWAY |
| NO DEVICEEvaluation of NO DEVICE during sedation | Device | NO DEVICE |
Primary outcome
Transpharyngeal distance during moderate-to-deep steady-state sedation.
Time frame: Five months
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].
Duration of manual airway support during PS for clinical procedures.
Time frame: Six months
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].
6 secondary outcomes
Transpharyngeal distance during mild steady-state sedation.
Time frame: Five months
Duration of interrupted capnometric monitoring during sedation.
Time frame: Six months
Duration of manual airway support during induction of steady-state sedation.
Time frame: Five months
Sedational comfort
Time frame: Six months
Conditions for sedation
Time frame: Six months
Conditions for procedural intervention
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Åkeson, Professor principal investigator
Lund University, Malmö, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAIRWAY and NO DEVICE in people with Airway Obstruction and Sedation Complication, run by Stairway Medical AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonas Åkeson, Professor (0708311113 ext. +46, jonas.akeson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transpharyngeal distance during moderate-to-deep steady-state sedation. (time frame: Five months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.