Respiratory InsufficiencyNIVNCT00885898
Out-of-Hospital Non-Invasive Ventilation for Patients With Acute Respiratory Failure
A study testing Non-invasive-ventilation and conventional treatment in people with Respiratory Insufficiency and Respiratory Failure, run by University of Göttingen at 1 site in Germany.
Trial summary
In the past, patients suffering from acute respiratory failure had to be treated with Oxygen and specific medication, or - if this had not been sufficient - had to be anesthesized and had to undergo endotracheal intubation for invasive ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Respiratory Failure
- What is being tested?
- Non-invasive-ventilation and conventional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2005to Apr 2009
- 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
- acute respiratory failure
- at least 18 years old
- cooperative
Who cannot join
- cardiac arrest
- respiratory arrest
- unconscious
- uncontrollable agitation
- less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Out-of-Hospital Non-Invasive Ventilation in Patients With Acute Respiratory Insufficiency
In the past, patients suffering from acute respiratory failure had to be treated with Oxygen and specific medication, or - if this had not been sufficient - had to be anesthesized and had to undergo endotracheal intubation for invasive ventilation. Nowadays, since emergency ventilators are available that can be used for non-invasive ventilation, the purpose of this study is to investigate if non-invasive ventilation is safe, feasible and effective for the treatment of acute respiratory failure and if less patients will need to be intubated out-of-hospital as well as in the further course.
Read the detailed description
Single center, prospective, randomized, intention-to-treat clinical trial. The study has been performed within a two tier EMS system of a major city. Prehospital emergency physicians are on scene in every patient enrolled to the study.
Patients with acute respiratory failure (SaO2 < 90%, respiratory rate > 20/min) were enrolled to the study using envelopes for randomisation for either "conventional" (O2 + medication) or "NIV." Vital signs have been documented as well as venous blood gases have been taken every 10 minutes after treatment has been started.
Primary endpoints are 28-day mortality, hospital-, ICU- and respirator-days, SAPS, SOFA II and complications. Secondary endpoints are out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure.
- Conditions
- Respiratory Insufficiency, Respiratory Failure
- Being tested
- Non-invasive-ventilation, conventional treatment
- Keywords
- Respiratory Insufficiency, Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive-ventilationProcedure or surgery
increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation
conventional treatmentProcedure or surgery
oxygen, diuretics, bronchodilators, positive inotropic drugs
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | "Non-invasive ventilation" Receives: Procedure: Non-invasive-ventilation |
| 2 | Active comparator | "Conventional" Receives: Procedure: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications
Measured: 30 days after enrollment
Secondary outcomes (1)
out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure
Measured: 30 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startMar 2005
- Primary completionJan 2007
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Göttingen
- Sponsor type
- University, hospital or other
- Investigators
- Markus S Roessler, Dr. med., M.D., D.E.A.A., EDIC, Study director, Department of Anesthesiology, Emergency- and Intensive Care Medicine, Georg-August-University Goettingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885898
- Sponsor's protocol ID
- 40/11/04 UGoettingen
- Acronym
- NIV
- Status last verified
- Apr 2009
- First submitted
- 20 Apr 2009
- Last updated
- 22 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Roessler M. [Non-invasive ventilation in prehospital emergency medicine]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2008 Apr;43(4):264-6. doi: 10.1055/s-2008-1076608. German.
PubMed 18409119
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out-of-Hospital Non-Invasive Ventilation in Patients With Acute Respiratory Insufficiency
- ClinicalTrials.gov ID
- NCT00885898
- Acronym / sponsor ID
- NIV / 40/11/04 UGoettingen
- Conditions
- Respiratory Insufficiency, Respiratory Failure
- Keywords
- Respiratory Insufficiency, Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of GöttingenUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Apr 2009 (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.
In the past, patients suffering from acute respiratory failure had to be treated with Oxygen and specific medication, or - if this had not been sufficient - had to be anesthesized and had to undergo endotracheal intubation for invasive ventilation. Nowadays, since emergency ventilators are available that can be used for non-invasive ventilation, the purpose of this study is to investigate if non-invasive ventilation is safe, feasible and effective for the treatment of acute respiratory failure and if less patients will need to be intubated out-of-hospital as well as in the further course.
Detailed description
Single center, prospective, randomized, intention-to-treat clinical trial. The study has been performed within a two tier EMS system of a major city. Prehospital emergency physicians are on scene in every patient enrolled to the study.
Patients with acute respiratory failure (SaO2 < 90%, respiratory rate > 20/min) were enrolled to the study using envelopes for randomisation for either "conventional" (O2 + medication) or "NIV." Vital signs have been documented as well as venous blood gases have been taken every 10 minutes after treatment has been started.
Primary endpoints are 28-day mortality, hospital-, ICU- and respirator-days, SAPS, SOFA II and complications. Secondary endpoints are out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Non-invasive-ventilation"Non-invasive ventilation" |
| 2 | Active comparator | Procedure: conventional treatment"Conventional" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute respiratory failure
- at least 18 years old
- cooperative
Key exclusion criteria (5 listed)
- cardiac arrest
- respiratory arrest
- unconscious
- uncontrollable agitation
- less than 18 years old
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-ventilationincreased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation | Procedure or surgery | 1 |
| conventional treatmentoxygen, diuretics, bronchodilators, positive inotropic drugs | Procedure or surgery | 2 |
Primary outcome
28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications
Time frame: 30 days after enrollment
1 secondary outcome
out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure
Time frame: 30 days after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2009.
- Background: PubMed 18409119Roessler M. [Non-invasive ventilation in prehospital emergency medicine]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2008 Apr;43(4):264-6. doi: 10.1055/s-2008-1076608. German.
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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.
Markus S Roessler, Dr. med., M.D., D.E.A.A., EDIC study director
Department of Anesthesiology, Emergency- and Intensive Care Medicine, Georg-August-University Goettingen, Germany
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 and conventional treatment in people with Respiratory Insufficiency and Respiratory Failure, run by University of Göttingen at 1 site in Germany.
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 3 inclusion and 5 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 22 Apr 2009. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications (time frame: 30 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00885898, which also lists 1 linked publication.
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 22 Apr 2009.