Mechanically Ventilated Patients Admitted to a MICUNCT01697215
Novel Device to Assess Endotracheal Tube Migration
An observational study of Mechanically Ventilated Patients Admitted to a MICU, run by The Cleveland Clinic at 1 site in United States.
Trial summary
To evaluate the ability of the SonarMed AirWave to provide clinicians with information that enables them to confirm continuous proper placement of the endotracheal tube. This initial study is prospective, observational, looking at CXR results, and comparing those to AirWave system output data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated Patients Admitted to a MICU
- What is being tested?
- AirWave
- Type of treatment
- Pill or oral medicine
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jun 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MICU Based
Who may be able to join
- Subjects will be eligible for inclusion in the study if they meet ALL of the following criteria:
- Oral or nasal endotracheal intubation, anticipated to last at least 48 hours
- Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm
- Subject must be at least 18 years old (no upper age limitation)
- English speaking patients/decision makers.
Who cannot join
- Subjects ventilated through a tracheostomy
- Subjects under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Device (AirWave™) to Assess Endotracheal Tube Migration.
To evaluate the ability of the SonarMed AirWave to provide clinicians with information that enables them to confirm continuous proper placement of the endotracheal tube. This initial study is prospective, observational, looking at CXR results, and comparing those to AirWave system output data.
- Being tested
- AirWave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirWaveOther
| Study group | Role | What they receive |
|---|---|---|
| Oral or nasal endotracheal intubation | Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers. Receives: Other: AirWave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR
Comparison of migration at 24 hours as measured by the AirWave system and portable CXR using a Bland-Altman analysis.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mechanically Ventilated Patients Admitted to a MICUStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriano Tonelli, The Cleveland Clinic
- Investigators
- Adriano Tonelli, MD, Principal investigator, The Cleveland Clinic Foundatin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697215
- Sponsor's protocol ID
- 111128-PIP
- Status last verified
- May 2025
- First submitted
- 21 Sep 2012
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Device (AirWave™) to Assess Endotracheal Tube Migration.
- ClinicalTrials.gov ID
- NCT01697215
- Acronym / sponsor ID
- 111128-PIP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Oct 2012 (estimated)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the ability of the SonarMed AirWave to provide clinicians with information that enables them to confirm continuous proper placement of the endotracheal tube. This initial study is prospective, observational, looking at CXR results, and comparing those to AirWave system output data.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral or nasal endotracheal intubation | – | Other: AirWaveOral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MICU Based
Key inclusion criteria (5 listed)
- Subjects will be eligible for inclusion in the study if they meet ALL of the following criteria:
- Oral or nasal endotracheal intubation, anticipated to last at least 48 hours
- Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm
- Subject must be at least 18 years old (no upper age limitation)
- English speaking patients/decision makers.
Key exclusion criteria (2 listed)
- Subjects ventilated through a tracheostomy
- Subjects under 18 years of age
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 |
|---|---|---|
| AirWave | Other | Oral or nasal endotracheal intubation |
Primary outcome
Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR
Time frame: 24 hours
Comparison of migration at 24 hours as measured by the AirWave system and portable CXR using a Bland-Altman analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Adriano Tonelli, MD principal investigator
The Cleveland Clinic Foundatin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanically Ventilated Patients Admitted to a MICU, run by The Cleveland Clinic at 1 site in United States.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 14 May 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal Tube Displacement Bias Measured by a Novel Device (AirWave) Compared to CXR (time frame: 24 hours). 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 14 May 2025.