PreoxygenationPREOXYNCT01232153
Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon
A study testing Non invasive ventilation in people with Preoxygenation, run by Hopital of Melun at 1 site in France.
Trial summary
Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoxygenation
- What is being tested?
- Non invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 1 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients needing chest tube intubation
Who cannot join
- Cardiac arrest
- Children
- Pregnancy
- Incompetents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service
Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions.
Read the detailed description
This trial will compare classical preoxygenation strategy with unidirectional valve autofilling balloon versus NIV.
- Conditions
- Preoxygenation
- Being tested
- Non invasive ventilation
- Keywords
- chest tube, preoxygenation, NIV, out-of-hospital, patients needing tracheal chest tube managed by Medical Mobile Emergency rescue services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ventilationDevice
Non invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| NIV preoxygenation | Active comparator | Not described Receives: Device: Non invasive ventilation |
| Classical preoxygenation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hypoxemia
SpO2 below 85%
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study start1 Mar 2017
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Why it stopped: departure without replacement of the principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreoxygenationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital of Melun
- Sponsor type
- University, hospital or other
- Collaborators
- Service d'Aide Médicale Urgente de Seine et Marne
- Responsible party
- Principal investigator, Sebastien Jochmans, MD, Hopital of Melun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232153
- Sponsor's protocol ID
- PREOXY
- Acronym
- PREOXY
- Status last verified
- Aug 2020
- First submitted
- 29 Oct 2010
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon. A Multicenter Randomized Controlled Trial in Mobile Medical Emergency Rescue Service
- ClinicalTrials.gov ID
- NCT01232153
- Acronym / sponsor ID
- PREOXY / PREOXY
- Conditions
- Preoxygenation
- Keywords
- chest tube, preoxygenation, NIV, out-of-hospital, patients needing tracheal chest tube managed by Medical Mobile Emergency rescue services
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: departure without replacement of the principal investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hopital of MelunUniversity, hospital or other
- Collaborators
- Service d'Aide Médicale Urgente de Seine et Marne
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 2 Nov 2010 (estimated)
- 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.
Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions.
Detailed description
This trial will compare classical preoxygenation strategy with unidirectional valve autofilling balloon versus NIV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIV preoxygenation | Active comparator | Device: Non invasive ventilation |
| Classical preoxygenation | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients needing chest tube intubation
Key exclusion criteria (4 listed)
- Cardiac arrest
- Children
- Pregnancy
- Incompetents
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 |
|---|---|---|
| Non invasive ventilationNon invasive ventilation | Device | NIV preoxygenation |
Primary outcome
length of hypoxemia
Time frame: 5 minutes
SpO2 below 85%
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive ventilation in people with Preoxygenation, run by Hopital of Melun at 1 site in France.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 2 Sep 2020. 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 France. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
length of hypoxemia (time frame: 5 minutes). 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 2 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.