NCT03278769

Brief Summary

The present study is an explorative analysis of the relationship between cerebral blood perfusion and oxygenation and lung mechanical variables at different ventilator settings. It is a safety study excluding patients with severe lung injury or brain edema.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

2.3 years

First QC Date

August 29, 2017

Last Update Submit

May 16, 2022

Conditions

Acute Brain InjuryVentilator-Induced Lung InjuryCerebrovascular Circulation

Outcome Measures

Primary Outcomes (2)

  • Intracranial pressure

    intracranial pressure increase with lung protective setting

    120 minutes

  • pressure reactivity index

    Diminished pressure reactivity index

    120 minutes

Study Arms (1)

Ventilator setting

EXPERIMENTAL

Positive end-expiratory pressure , Tidal volume

Procedure: Lung protective ventilator settings

Interventions

Lung protective ventilator settingsPROCEDURE

Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight

Ventilator setting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any tracheally intubated or tracheotomized adult patient with ABI with GCS\< 9 on controlled ventilation requiring continuous ICP measurement.
  • Proxy informed consent from relatives.

You may not qualify if:

  • ICP \> 22 mmHg before treatment of high ICP
  • Acute respiratory failure defined as partial pressure of oxygen/ inspiratory oxygen fraction (PaO2/FiO2) ratio \< 40 kPa and Xray pathology
  • History of pulmonary disese: Chronic respiratory failure diagnosis stage III and IV in the GOLD classification, pulmectomy, lobectomy or restrictive lung disease.
  • Body mass index (BMI) \> 35.
  • Known right or biventricular cardiac failure with cardiac index \< 2,5 L/min/m2 or ejection fracture \< 40 %.
  • Refractory hypovolemia as diagnosed with pulse pressure variation \> 12 % with tidal volume 8 ml/predicted bodyweight (intubated on controlled ventilation) or passive leg rise test with \> 10 % increase in stroke volume measured by VTI echocardiography or PICCO.
  • Medulla lesion that affect the autonomic nervous system.
  • Patients who has undergone decompressive craniectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital North Norway

Tromsø, Troms, 9010, Norway

Location

Related Publications (4)

  • Smielewski P, Lavinio A, Timofeev I, Radolovich D, Perkes I, Pickard JD, Czosnyka M. ICM+, a flexible platform for investigations of cerebrospinal dynamics in clinical practice. Acta Neurochir Suppl. 2008;102:145-51. doi: 10.1007/978-3-211-85578-2_30.

    PMID: 19388307BACKGROUND

  • Koutsoukou A, Katsiari M, Orfanos SE, Kotanidou A, Daganou M, Kyriakopoulou M, Koulouris NG, Rovina N. Respiratory mechanics in brain injury: A review. World J Crit Care Med. 2016 Feb 4;5(1):65-73. doi: 10.5492/wjccm.v5.i1.65. eCollection 2016 Feb 4.

    PMID: 26855895BACKGROUND

  • Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.

    PMID: 27334266BACKGROUND

  • Beqiri E, Smielewski P, Guerin C, Czosnyka M, Robba C, Bjertnaes L, Frisvold SK. Neurological and respiratory effects of lung protective ventilation in acute brain injury patients without lung injury: brain vent, a single centre randomized interventional study. Crit Care. 2023 Mar 20;27(1):115. doi: 10.1186/s13054-023-04383-z.

    PMID: 36941683DERIVED

MeSH Terms

Conditions

Brain InjuriesVentilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesLung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Shirin K Frisvold

    University Hospital of North Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, PhD

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 12, 2017

Study Start

June 1, 2019

Primary Completion

September 1, 2021

Study Completion

January 1, 2022

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)