Traumatic Brain InjuryNCT01955785
Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury
A study of Traumatic Brain Injury, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and mechanically ventilated in order to secure a stable PaCO2. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2013to Sep 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Informed consent obtained from the patients next-of-kin.
- moderate or severe TBI according to Head Injury Severity Scale (Glasgow Coma Scale (GCS) score 3-13).
- treated at the neurosurgical ICU or the main ICU at St Olav University Hospital.
- intubated and receiving controlled mechanical ventilation.
- continuous measurement of ICP with either an intraventricular or an intraparenchymal pressure monitor device.
- sedation to a level of sedation corresponding to MAAS (Motor Activity Assessment Score) 0 or 1 with continuous intravenous infusions of midazolam/propofol and morphine/fentanyl/remifentanil14.
Who cannot join
- Pregnancy
- ICP above 25 mmHg
- ongoing cerebral anti edema therapy corresponding to Step III at St Olav University Hospital therapy guideline
- continuous external drainage of cerebrospinal fluid (CSF)
- Clinical pulmonary condition prohibiting changes in respiratory therapy
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept Intensive Care Medicine, St Olavs University Hospital
Trondheim, 7006
About this study
Official title: Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury: A Randomised Comparison of Pressure Controlled Ventilation and Pressure Regulated Volume Controlled Ventilation
Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and mechanically ventilated in order to secure a stable PaCO2. This study compares two ventilation modus; Pressure Controlled Ventilation (PC) and Pressure Regulated Volume Controlled ventilation (PRVC) in order to observe which of the two ventilation strategies results in a more stable ICP and arterial CO2 pressure (PaCO2).
- Conditions
- Traumatic Brain Injury
- Being tested
- pressure controlled ventilator, Pressure Regulated Volume Controlled Ventilator
- Keywords
- Traumatic brain injury, Intracranial pressure, Ventilation, Respiratory therapy
- Medical subject headings
- Brain Injuries, Traumatic, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure controlled ventilatorDevice
Pressure Regulated Volume Controlled VentilatorDevice
| Study group | Role | What they receive |
|---|---|---|
| PC ventilation | Active comparator | Intervention with pressure controlled ventilator Receives: Device: pressure controlled ventilator |
| PRVC ventilation | Active comparator | Intervention with Pressure Regulated Volume Controlled Ventilator Receives: Device: Pressure Regulated Volume Controlled Ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICP
Each study period is two hours. All patients receive several study periods (max number 6) in a N=1 design
Measured: Two hours
Secondary outcomes (1)
PaCO2
Each subject is studied in several study periods each of two hours duration (max number 6 periods). N=1 design
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionSep 2015
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 Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pål Klepstad, MD PhD, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955785
- Sponsor's protocol ID
- 2013/1346
- Status last verified
- Jul 2016
- First submitted
- 30 Sep 2013
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Schirmer-Mikalsen K, Vik A, Skogvoll E, Moen KG, Solheim O, Klepstad P. Intracranial Pressure During Pressure Control and Pressure-Regulated Volume Control Ventilation in Patients with Traumatic Brain Injury: A Randomized Crossover trial. Neurocrit Care. 2016 Jun;24(3):332-41. doi: 10.1007/s12028-015-0208-8.
PubMed 26503512
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury: A Randomised Comparison of Pressure Controlled Ventilation and Pressure Regulated Volume Controlled Ventilation
- ClinicalTrials.gov ID
- NCT01955785
- Acronym / sponsor ID
- 2013/1346
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, Intracranial pressure, Ventilation, Respiratory therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Oct 2013 (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.
Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and mechanically ventilated in order to secure a stable PaCO2. This study compares two ventilation modus; Pressure Controlled Ventilation (PC) and Pressure Regulated Volume Controlled ventilation (PRVC) in order to observe which of the two ventilation strategies results in a more stable ICP and arterial CO2 pressure (PaCO2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PC ventilation | Active comparator | Device: pressure controlled ventilatorIntervention with pressure controlled ventilator |
| PRVC ventilation | Active comparator | Device: Pressure Regulated Volume Controlled VentilatorIntervention with Pressure Regulated Volume Controlled Ventilator |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent obtained from the patients next-of-kin.
- moderate or severe TBI according to Head Injury Severity Scale (Glasgow Coma Scale (GCS) score 3-13).
- treated at the neurosurgical ICU or the main ICU at St Olav University Hospital.
- intubated and receiving controlled mechanical ventilation.
- continuous measurement of ICP with either an intraventricular or an intraparenchymal pressure monitor device.
Key exclusion criteria (5 listed)
- Pregnancy
- ICP above 25 mmHg
- ongoing cerebral anti edema therapy corresponding to Step III at St Olav University Hospital therapy guideline
- continuous external drainage of cerebrospinal fluid (CSF)
- Clinical pulmonary condition prohibiting changes in respiratory therapy
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 |
|---|---|---|
| pressure controlled ventilator | Device | PC ventilation |
| Pressure Regulated Volume Controlled Ventilator | Device | PRVC ventilation |
Primary outcome
ICP
Time frame: Two hours
Each study period is two hours. All patients receive several study periods (max number 6) in a N=1 design
1 secondary outcome
PaCO2
Time frame: Two hours
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 29 Jul 2016.
- Results publication: PubMed 26503512Schirmer-Mikalsen K, Vik A, Skogvoll E, Moen KG, Solheim O, Klepstad P. Intracranial Pressure During Pressure Control and Pressure-Regulated Volume Control Ventilation in Patients with Traumatic Brain Injury: A Randomized Crossover trial. Neurocrit Care. 2016 Jun;24(3):332-41. doi: 10.1007/s12028-015-0208-8.
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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.
Pål Klepstad, MD PhD principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Traumatic Brain Injury, run by Norwegian University of Science and Technology 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 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 29 Jul 2016. 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?
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?
ICP (time frame: Two hours). 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 NCT01955785, 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 29 Jul 2016.