Respiratory Treatment of Patients With Moderate and Sever... | NCT01955785

Studies
Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

NCT01955785

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jul 29, 2016Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

Traumatic Brain Injury

Interventions

pressure controlled ventilator
Pressure Regulated Volume Controlled Ventilator

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Sep 30, 2013

First Submission Date that Met QC Criteria

Oct 7, 2013

First Posted Date

Oct 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2016

Last Update Posted Date

Jul 29, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PC ventilation	Active Comparator	Intervention with pressure controlled ventilator	Device: pressure controlled ventilator
PRVC ventilation	Active Comparator	Intervention with Pressure Regulated Volume Controlled Ventilator	Device: Pressure Regulated Volume Controlled Ventilator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pressure controlled ventilator	Device		PC ventilation
Pressure Regulated Volume Controlled Ventilator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ICP	Each study period is two hours. All patients receive several study periods (max number 6) in a N=1 design	Two hours

Secondary Outcomes

Measure	Description	Time Frame
PaCO2	Each subject is studied in several study periods each of two hours duration (max number 6 periods). N=1 design	Two hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pål Klepstad, MD PhD	National Taiwan Normal University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept Intensive Care Medicine, St Olavs University Hospital		Trondheim		7006	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26503512	Result	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.

ID	Term
D000070642	Brain Injuries, Traumatic
D053120	Respiratory Aspiration

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases