AtelectasisNCT02285894
Can 10 Seconds Inspiratory Hold Open Atelectasis in Mechanically Ventilated Patients?
A study testing Inspiratory hold in people with Atelectasis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study evaluates whether sustaining inspiratory pressure for 10 seconds at a time can open collapsed lung areas in non-dependant regions of the lung in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis
- What is being tested?
- Inspiratory hold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2014to Aug 2015
- 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
- Continuously or intermittently mechanically ventilated with artificial airway (endotracheal tube or tracheostomy tube)
- Pressure controlled or pressure supported ventilator mode
- PEEP ≤ 12 cm H2O, registered peak pressure ≤ 32 cm H2O
- Non-ventilated lung regions according to E.I.T. measurements
- Richmond Agitation Score 0 -(-5)
- Circulatory stable or stabilized
Who cannot join
- Pregnancy
- BMI > 50
- Pacemaker or other electrically active implants
- Skin lesions, wounds or bandages on chest area where E.I.T. belt needs to be placed
- Undrained pneumothorax
- Pulsating air-mattress
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- Unstable skeletal injury to spinal column
- Recent brain injury or spinal chord injury
- Recent injury to heart, to major blood vessels in chest, to major airways or to the oesophagus.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo university Hospital, Ullevål
Oslo, Oslo, 0450
Sarah LB Wilberg, Bachelor, +4795808290, sara-wi@online.no
Knut Gaustad, MD, +4741552576, knut.gaustad@getmail.no
About this study
Official title: Can 10 Seconds Inspiratory Hold Open Atelectasis in Mechanically Ventilated Patients? A Pilot Study.
This study evaluates whether sustaining inspiratory pressure for 10 seconds at a time can open collapsed lung areas in non-dependant regions of the lung in mechanically ventilated patients.
Read the detailed description
Collapse of lung volume, atelectasis, is a common complication in sedated and mechanically ventilated patients. In adults the atelectasis occur mainly in the dependant areas of the lung. In this study the investigators examine whether these atelectasis can be opened by repeatedly sustaining the inspiratory pressure for 10 seconds when the patient has been positioned so that the atelectasis is located in a non-dependant position. Furthermore, the investigators examine how many times the inspiratory pressure needs to be sustained before the atelectasis is opened and at what pressure.
- Conditions
- Atelectasis
- Being tested
- Inspiratory hold
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory holdOther
Sustainment of the ventilators inspiratory pressure for 10 seconds at a time
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory hold | Experimental | Mechanical inspiratory pressure held for 10 seconds at a time. Receives: Other: Inspiratory hold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation in previously non-ventilated lung tissue
Registered using electrical impedance tomography, E.I.T., via PulmoVista500 by Dräger Medical
Measured: During intervention and for 30 minutes after ended intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Nina K Vøllestad, Dr.Scient, Principal investigator, University of OsloHarald Noddeland, PhD, MD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285894
- Sponsor's protocol ID
- 2014/375 (REK)
- Status last verified
- Nov 2014
- First submitted
- 5 Nov 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can 10 Seconds Inspiratory Hold Open Atelectasis in Mechanically Ventilated Patients? A Pilot Study.
- ClinicalTrials.gov ID
- NCT02285894
- Acronym / sponsor ID
- 2014/375 (REK)
- Conditions
- Atelectasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 7 Nov 2014 (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.
This study evaluates whether sustaining inspiratory pressure for 10 seconds at a time can open collapsed lung areas in non-dependant regions of the lung in mechanically ventilated patients.
Detailed description
Collapse of lung volume, atelectasis, is a common complication in sedated and mechanically ventilated patients. In adults the atelectasis occur mainly in the dependant areas of the lung. In this study the investigators examine whether these atelectasis can be opened by repeatedly sustaining the inspiratory pressure for 10 seconds when the patient has been positioned so that the atelectasis is located in a non-dependant position. Furthermore, the investigators examine how many times the inspiratory pressure needs to be sustained before the atelectasis is opened and at what pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inspiratory hold | Experimental | Other: Inspiratory holdMechanical inspiratory pressure held for 10 seconds at a time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Continuously or intermittently mechanically ventilated with artificial airway (endotracheal tube or tracheostomy tube)
- Pressure controlled or pressure supported ventilator mode
- PEEP ≤ 12 cm H2O, registered peak pressure ≤ 32 cm H2O
- Non-ventilated lung regions according to E.I.T. measurements
- Richmond Agitation Score 0 -(-5)
Key exclusion criteria (9 listed)
- Pregnancy
- BMI > 50
- Pacemaker or other electrically active implants
- Skin lesions, wounds or bandages on chest area where E.I.T. belt needs to be placed
- Undrained pneumothorax
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 |
|---|---|---|
| Inspiratory holdSustainment of the ventilators inspiratory pressure for 10 seconds at a time | Other | Inspiratory hold |
Primary outcome
Ventilation in previously non-ventilated lung tissue
Time frame: During intervention and for 30 minutes after ended intervention
Registered using electrical impedance tomography, E.I.T., via PulmoVista500 by Dräger Medical
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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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.
Nina K Vøllestad, Dr.Scient principal investigator
University of Oslo
Harald Noddeland, PhD, MD 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 study testing Inspiratory hold in people with Atelectasis, run by Oslo 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 24 Nov 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah LB Wilberg, Bachelor (+47 95 80 82 90, sara-wi@online.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation in previously non-ventilated lung tissue (time frame: During intervention and for 30 minutes after ended intervention). 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 24 Nov 2014.