Post-Traumatic Respiratory FailurePhase 4NCT00557752
Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma
A Phase 4 study testing Non-invasive ventilation in people with Post-Traumatic Respiratory Failure, run by Hospital Virgen de la Salud at 2 sites in Spain.
Trial summary
Severe post-traumatic hypoxia is mainly due to lung contusion. The intubation rate of these patients is near 20%. Treatment before intubation is needed, is based on pain control with epidural anesthesia and oxygen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Respiratory Failure
- 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
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2005to Jun 2008
- Phase
- Phase 4
- 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
- Age > 18 years.
- Informed consent obtained.
- pO2/FiO2 <200 for more than 8 consecutive hours in the first 48 hours after thoracic trauma.
Who cannot join
- Orotracheal intubation indicated for any other reason.
- Standard contraindication for non-invasive ventilation (active gastro-intestinal haemorrhage, low level of consciousness, multiorgan failure, airway control problems, lack of cooperation, hemodynamic instability).
- Severe traumatic brain injury.
- Facial trauma with pneumocephalus, skull base fracture, orbit base fracture, any facial fracture involving a sinus.
- Cervical injury with specific treatment contraindicating a facial mask.
- Bronco-pleural fistula.
- Gastro-intestinal trauma.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital 12 de Octubre
Madrid, Madrid, 28045
Hospital Virgen de la Salud
Toledo, Toledo, 45004
About this study
Official title: Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial
- Severe post-traumatic hypoxia is mainly due to lung contusion. The intubation rate of these patients is near 20%.
- Treatment before intubation is needed, is based on pain control with epidural anesthesia and oxygen.
- The investigators' hypothesis is that adding non-invasive mechanical ventilation to the standard treatment can reduce the intubation rate if applied early in the course of the disease.
- As thoracic trauma is often associated with injuries in other body regions that may increase the complications of the technique, specific contraindications have been described.
- Conditions
- Post-Traumatic Respiratory Failure
- Being tested
- Non-invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationDevice
Applied continuously for the first 24 hours, then every 24 hours, trial of discontinuation. Interface specific for the associated injuries.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Addition to the standard therapy of non-invasive mechanical ventilation. Continuously for the first 24 hours, then trials to discontinuation every 24 hours. Interface adjusted for the associated injuries. Receives: Device: Non-invasive ventilation |
| 2 | No intervention | Standard therapy for severe post-traumatic hypoxia: pain control with epidural anesthesia and oxygen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation rate
Measured: 1 month
Secondary outcomes (3)
Pneumothorax rate
Measured: 1 month
Pneumonia rate
Measured: 1 month
Intensive Care Unit stay
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startSep 2005
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Review Board stopped the study after interim analysis reaching stopping rule for efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Respiratory FailureStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Virgen de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Investigators
- Gonzalo Hernandez, Dr., Principal investigator, Hospital Virgen de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557752
- Sponsor's protocol ID
- 06001-00
- Status last verified
- Feb 2009
- First submitted
- 13 Nov 2007
- Last updated
- 9 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. doi: 10.1136/thorax.57.3.192. No abstract available.
PubMed 11867822Hernandez G, Fernandez R, Lopez-Reina P, Cuena R, Pedrosa A, Ortiz R, Hiradier P. Noninvasive ventilation reduces intubation in chest trauma-related hypoxemia: a randomized clinical trial. Chest. 2010 Jan;137(1):74-80. doi: 10.1378/chest.09-1114. Epub 2009 Sep 11.
PubMed 19749006
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00557752
- Acronym / sponsor ID
- 06001-00
- Conditions
- Post-Traumatic Respiratory Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Review Board stopped the study after interim analysis reaching stopping rule for efficacy.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Virgen de la SaludUniversity, hospital or other
- Collaborators
- Fundación Mutua Madrileña
- Study start
- Sep 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 14 Nov 2007 (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.
- Severe post-traumatic hypoxia is mainly due to lung contusion. The intubation rate of these patients is near 20%.
- Treatment before intubation is needed, is based on pain control with epidural anesthesia and oxygen.
- The investigators' hypothesis is that adding non-invasive mechanical ventilation to the standard treatment can reduce the intubation rate if applied early in the course of the disease.
- As thoracic trauma is often associated with injuries in other body regions that may increase the complications of the technique, specific contraindications have been described.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Non-invasive ventilationAddition to the standard therapy of non-invasive mechanical ventilation. Continuously for the first 24 hours, then trials to discontinuation every 24 hours. Interface adjusted for the associated injuries. |
| 2 | No intervention | –Standard therapy for severe post-traumatic hypoxia: pain control with epidural anesthesia and oxygen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years.
- Informed consent obtained.
- pO2/FiO2 <200 for more than 8 consecutive hours in the first 48 hours after thoracic trauma.
Key exclusion criteria (7 listed)
- Orotracheal intubation indicated for any other reason.
- Standard contraindication for non-invasive ventilation (active gastro-intestinal haemorrhage, low level of consciousness, multiorgan failure, airway control problems, lack of cooperation, hemodynamic instability).
- Severe traumatic brain injury.
- Facial trauma with pneumocephalus, skull base fracture, orbit base fracture, any facial fracture involving a sinus.
- Cervical injury with specific treatment contraindicating a facial mask.
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 ventilationApplied continuously for the first 24 hours, then every 24 hours, trial of discontinuation. Interface specific for the associated injuries. | Device | 1 |
Primary outcome
Intubation rate
Time frame: 1 month
3 secondary outcomes
Pneumothorax rate
Time frame: 1 month
Pneumonia rate
Time frame: 1 month
Intensive Care Unit stay
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Review Board stopped the study after interim analysis reaching stopping rule for efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
- Results publication: PubMed 11867822British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. doi: 10.1136/thorax.57.3.192. No abstract available.
- Derived from this study: PubMed 19749006Hernandez G, Fernandez R, Lopez-Reina P, Cuena R, Pedrosa A, Ortiz R, Hiradier P. Noninvasive ventilation reduces intubation in chest trauma-related hypoxemia: a randomized clinical trial. Chest. 2010 Jan;137(1):74-80. doi: 10.1378/chest.09-1114. Epub 2009 Sep 11.
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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.
Gonzalo Hernandez, Dr. principal investigator
Hospital Virgen de la Salud
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-invasive ventilation in people with Post-Traumatic Respiratory Failure, run by Hospital Virgen de la Salud at 2 sites in Spain.
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 7 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: stopped early, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Review Board stopped the study after interim analysis reaching stopping rule for efficacy.). Results are not available in the source record.
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?
Intubation rate (time frame: 1 month). 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 NCT00557752, which also lists 2 linked publications.
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 9 Feb 2009.