NCT01376518

Brief Summary

The aim of the present study is to characterize the influence of an elevated positive end-expiratory pressure in patients with acute respiratory distress syndrome or acute lung injury on the cerebrovascular autoregulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 14, 2011

Last Update Submit

June 19, 2020

Conditions

Keywords

acute respiratory distress syndromeacute lung injurycerebrovascular autoregulationtranscranial Dopplerventilation

Outcome Measures

Primary Outcomes (1)

  • Integrity of the cerebrovascular autoregulation (CA)

    Cerebrovascular autoregulation will be calculated as a moving correlation index (Mx) from the cerebral blood flow velocity and the arterial blood pressure. It is a parameter without unit (index).

    30 Minutes

Study Arms (1)

respiratory failure

patients with respiratory failure and need of high positive end-expiratory pressure ventilation.

Procedure: positive end-expiratory pressure

Interventions

Elevation of positive end-expiratory failure for recruitment

Also known as: PEEP
respiratory failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients on intensive care unit with acute respiratory failure

You may qualify if:

  • respiratory failure
  • Age \>18 years
  • Invasive ventilation

You may not qualify if:

  • Sepsis
  • preexisting cerebral illness
  • traumatic brain injury
  • meningitis or encephalitis
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University medical centre

Mainz, 55131, Germany

Location

Related Publications (1)

  • Schramm P, Closhen D, Felkel M, Berres M, Klein KU, David M, Werner C, Engelhard K. Influence of PEEP on cerebral blood flow and cerebrovascular autoregulation in patients with acute respiratory distress syndrome. J Neurosurg Anesthesiol. 2013 Apr;25(2):162-7. doi: 10.1097/ANA.0b013e31827c2f46.

MeSH Terms

Conditions

Respiratory InsufficiencyRespiratory Distress SyndromeAcute Lung InjuryRespiratory Aspiration

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesLung DiseasesLung InjuryPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Patrick Schramm, MD

    Department of Anesthesiology, University medicine Mainz, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician

Study Record Dates

First Submitted

June 14, 2011

First Posted

June 20, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 22, 2020

Record last verified: 2020-06

Locations