NCT01109355

Brief Summary

Intrathoracic positive pressure may lead to a change hemodynamics, with repercussions for the intracranial compartment, thereby altering intracranial pressure (ICP) and cerebral perfusion pressure (CPP). This effect may become more intense when using high positive end expiratory pressure (PEEP) values. The aim of the present study was to measure the impact of different PEEP values on ICP, CPP and mean arterial pressure (MAP). MAP, whereas high PEEP values increase ICP, although without clinical relevance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable stroke

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2010

Completed
Last Updated

April 23, 2010

Status Verified

December 1, 2009

Enrollment Period

6 months

First QC Date

April 19, 2010

Last Update Submit

April 22, 2010

Conditions

Keywords

PEEPPatients with hemorrhage stroke under mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Measurement of intracranial pressure

    The ICP monitoring catheter was kept closed for drainage and open for monitoring, since the arrival of the surgical block, was only open for drainage if there was an increase in ICP above 20 mmHg.

Secondary Outcomes (2)

  • Effect of different values of PEEP on lung mechanics

  • Effect of different PEEP levels on aspects hemodynamic

Interventions

To perform the evaluation of lung mechanics ventilatory mode was changed to control volume with the following parameters: tidal volume (Vt) = 8ml/kg weight, peak flow (PF) = 6 x minute volume, fraction of inspired O2 (FiO2) = 40%, respiratory rate (RR) = 16 bpm, sensitivity = 1 cmH2O. The following variables were monitored: PIC, Blood Pressure (BP), heart rate (HR), peak pressure in the airways (pp.) and plateau pressure of the respiratory system (Ppl.), these values were monitored with PEEP = 5 cmH2O. PEEP employed ranged from 0 to 14 cmH2O. To eliminate a possible physiological accommodation by the progressive increase of PEEP, the range of values was determined by drawing a sealed envelope for each patient, ranging from 2 to 2 cmH2O.

At each value of PEEP the patient was ventilated for a period of five minutes to carry out monitoring of ICP, BP, HR, PPC and peripheral oxygen saturation (SpO2). The ICP monitoring catheter was kept closed for drainage and open for monitoring, since the arrival of the surgical block, was only open for drainage if there was an increase in ICP above 20 mmHg.

Eligibility Criteria

Age42 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients with acute CVA
  • presence of ventricular drainage catheter for invasive monitoring of ICP
  • without intracranial hypertension.

You may not qualify if:

  • intracranial hypertension
  • hemodynamic instability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Português

Recife, Pernambuco, Brazil

Location

Related Publications (2)

  • Pillai S, Praharaj SS, Rao GS, Kolluri VR. Cerebral perfusion pressure management of severe diffuse head injury: effect on brain compliance and intracranial pressure. Neurol India. 2004 Mar;52(1):67-71.

  • Mayer SA, Copeland D, Bernardini GL, Boden-Albala B, Lennihan L, Kossoff S, Sacco RL. Cost and outcome of mechanical ventilation for life-threatening stroke. Stroke. 2000 Oct;31(10):2346-53. doi: 10.1161/01.str.31.10.2346.

MeSH Terms

Conditions

StrokeHemorrhage

Interventions

HemodynamicsIntracranial Pressure

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaCerebrospinal Fluid PressureNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Roberto Campelo

    Universidade Federal de Pernambuco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 23, 2010

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

April 23, 2010

Record last verified: 2009-12

Locations