Spinal Cord InjuryPhase 2NCT01046175
Effect of Air-stacking on Peak Cough Flow in Patients With Acute Cervical or High Thoracic Spinal Cord Injury
A Phase 2 study testing Air-stacking with a manual resuscitator and Air-stacking with ventilator in people with Spinal Cord Injury and Tetraplegia, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
Respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury, especially among cervical and higher thoracic injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Tetraplegia
- What is being tested?
- Air-stacking with a manual resuscitator and Air-stacking with ventilator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2010to Jun 2011
- Phase
- Phase 2
- 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 cervical or high thoracic spinal cord injury admitted to the ICU
Who cannot join
- substantial abdominal or thoracic injury
- substantial brain damage
- intubated or tracheostomized patients
- not able to cooperate
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two Different Air-stacking Techniques, Combined With Manually Assisted Cough, on Peak Cough Flow (PCF) in Patients With Acute Cervical or High Thoracic Spinal Cord Injury
Respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury, especially among cervical and higher thoracic injuries. Both inspiratory and expiratory function are often severely decreased, leading to respiratory complications, such as atelectasis, pneumonia and ventilatory failure. The prevention of these respiratory complications needs to begin immediately after injury. To achieve effective expelling of secretions before they form mucus plugs, it is essential to improve patients ability to cough. Manually assisting the cough is one way of increasing cough flow, but an effective cough also requires adequate lung volumes. The emphasis should therefore be on expansion of the lungs before coughing. One way of expanding the lungs is by air-stacking. In air-stacking insufflations are stacked in the lungs to maximally expand them. Cough can be valued by measuring Peak Cough Flow (PCF). By combining air-stacking with manually assisted cough the PCF can be increased sufficiently. The aim of this study is to compare the effect of two different air-stacking techniques on PCF, air-stacking on a respirator versus air-stacking with a manual resuscitator.
- Conditions
- Spinal Cord Injury, Tetraplegia
- Being tested
- Air-stacking with a manual resuscitator, Air-stacking with ventilator
- Keywords
- Respiratory complications, respiratory insufficiency, respiratory therapy
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-stacking with a manual resuscitatorProcedure or surgery
Also called Lung volume recruitment technique
Stacking air into the lungs up to maximal insufflation capacity (MIC)with a manual resuscitator
Air-stacking with ventilatorProcedure or surgery
Also called Lung volume recruitment technique
Stacking air into the lungs to maximal insufflation capacity (MIC) with ventilator
| Study group | Role | What they receive |
|---|---|---|
| Airstacking with manual resuscitator | Experimental | Air-stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a manual resuscitator. Receives: Procedure: Air-stacking with a manual resuscitator |
| Air-stacking with ventilator | Active comparator | Air-stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a ventilator. Receives: Procedure: Air-stacking with ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak cough flow (PCF)
Measured: 2 weeks
Secondary outcomes (2)
Patient preference of air-stacking technique
Measured: 2 weeks
Physiotherapist preference of air-stacking technique
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011 (estimated)
- Study completionJun 2011 (estimated)
Why it stopped: Lack of patients. Investigator changed job.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Helene L Soberg, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046175
- Sponsor's protocol ID
- S-09326b
- Status last verified
- Dec 2009
- First submitted
- 22 Dec 2009
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Air-stacking Techniques, Combined With Manually Assisted Cough, on Peak Cough Flow (PCF) in Patients With Acute Cervical or High Thoracic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01046175
- Acronym / sponsor ID
- S-09326b
- Conditions
- Spinal Cord Injury, Tetraplegia
- Keywords
- Respiratory complications, respiratory insufficiency, respiratory therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patients. Investigator changed job.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 11 Jan 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.
Respiratory complications continue to be one of the leading causes of morbidity and mortality in people with spinal cord injury, especially among cervical and higher thoracic injuries. Both inspiratory and expiratory function are often severely decreased, leading to respiratory complications, such as atelectasis, pneumonia and ventilatory failure. The prevention of these respiratory complications needs to begin immediately after injury. To achieve effective expelling of secretions before they form mucus plugs, it is essential to improve patients ability to cough. Manually assisting the cough is one way of increasing cough flow, but an effective cough also requires adequate lung volumes. The emphasis should therefore be on expansion of the lungs before coughing. One way of expanding the lungs is by air-stacking. In air-stacking insufflations are stacked in the lungs to maximally expand them. Cough can be valued by measuring Peak Cough Flow (PCF). By combining air-stacking with manually assisted cough the PCF can be increased sufficiently. The aim of this study is to compare the effect of two different air-stacking techniques on PCF, air-stacking on a respirator versus air-stacking with a manual resuscitator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airstacking with manual resuscitator | Experimental | Procedure: Air-stacking with a manual resuscitatorAir-stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a manual resuscitator. |
| Air-stacking with ventilator | Active comparator | Procedure: Air-stacking with ventilatorAir-stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a ventilator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute cervical or high thoracic spinal cord injury admitted to the ICU
Key exclusion criteria (5 listed)
- substantial abdominal or thoracic injury
- substantial brain damage
- intubated or tracheostomized patients
- not able to cooperate
- pregnant women
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 |
|---|---|---|
| Air-stacking with a manual resuscitatorAlso: Lung volume recruitment techniqueStacking air into the lungs up to maximal insufflation capacity (MIC)with a manual resuscitator | Procedure or surgery | Airstacking with manual resuscitator |
| Air-stacking with ventilatorAlso: Lung volume recruitment techniqueStacking air into the lungs to maximal insufflation capacity (MIC) with ventilator | Procedure or surgery | Air-stacking with ventilator |
Primary outcome
Peak cough flow (PCF)
Time frame: 2 weeks
2 secondary outcomes
Patient preference of air-stacking technique
Time frame: 2 weeks
Physiotherapist preference of air-stacking technique
Time frame: 2 weeks
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 15 Nov 2010.
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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.
Helene L Soberg, PhD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Air-stacking with a manual resuscitator and Air-stacking with ventilator in people with Spinal Cord Injury and Tetraplegia, run by Ullevaal University Hospital at 1 site in Norway.
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 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: withdrawn, as of the sponsor's last update on 15 Nov 2010. 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 Norway. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Peak cough flow (PCF) (time frame: 2 weeks). 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 15 Nov 2010.