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Positive and Expiratory Pressure and Hemorrhagic Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109355
First Posted: April 23, 2010
Last Update Posted: April 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidade Federal de Pernambuco
  Purpose
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.

Condition Intervention
Stroke Hemorrhage Other: lung mechanics ventilatory Other: Hemodynamic and intracranial pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Positive End Expiratory Pressure on Cerebral Perfusion Pressure in Adult Patients With Hemorrhagic Stroke

Further study details as provided by Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Effect of different values of PEEP on lung mechanics
    - Lung compliance:During the assessment protocol was changed to pressure control ventilation mode with the following values of ventilatory parameters: Pp = 30 cm H2O, inspiratory time = 1s; FiO2 = 40%, RR = 16 bpm; Sensitivity = 1 cmH2O. PEEP employed ranged from 0 to 14 cmH2O.

  • Effect of different PEEP levels on aspects hemodynamic
    At each value of PEEP the patient was ventilated for a period of five minutes to carry out monitoring of heart rate and cerebral perfusion pressure(CPP).


Enrollment: 25
Study Start Date: January 2008
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: lung mechanics ventilatory
    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.
    Other: Hemodynamic and intracranial pressure
    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.
Detailed Description:
This study is a prospective clinical trial, developed in the neurological intensive care unit approved by the ethics committee and research in humans. The charge of each patient had information about the study through the completion of informed consent and signed him when he agreed. Were the following inclusion criteria: adult patients with acute CVA and presence of ventricular drainage catheter for invasive monitoring of ICP and without intracranial hypertension. Were adopted as exclusion criteria: increased intracranial pressure, hemodynamic instability as a criterion of loss was used to expressions of interest in charge to leave. All patients completed the study. <br>All patients were from the surgical implantation of the ventricular catheter, arriving to the ICU intubated orally and manually ventilated with an Ambu bag. Were subjected to routine procedures: adjusting the mechanical ventilator (Inter5, Intermed, BR) during assisted controlled cycled pressure and facility to monitor vital signs. After thirty minutes of stable ICU patient in a supine position with head elevated 30 °, the protocol was initiated to assess the impact of PEEP on ICP. 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. <br>During the assessment protocol was changed to pressure control ventilation mode with the following values of ventilatory parameters: Pp = 30 cm H2O, inspiratory time = 1s; FiO2 = 40%, RR = 16 bpm; Sensitivity = 1 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. <br>The monitoring was carried out using the multiparameter monitor (Siemens 7000). For ICP monitoring the ventricular catheter was connected to a pressure transducer and this monitor. <br>After the parameters evaluated with seven different PEEP values, the ventilatory mode was changed again to control volume again to evaluate pulmonary mechanics with the same initial parameters.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • intracranial hypertension
  • hemodynamic instability.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109355


Locations
Brazil
Hospital Português
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
Study Chair: Roberto Campelo Universidade Federal de Pernambuco
  More Information

Additional Information:
Publications:
Responsible Party: Wildberg Alencar, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT01109355     History of Changes
Other Study ID Numbers: Berg 01
First Submitted: April 19, 2010
First Posted: April 23, 2010
Last Update Posted: April 23, 2010
Last Verified: December 2009

Keywords provided by Universidade Federal de Pernambuco:
PEEP
Patients with hemorrhage stroke under mechanical ventilation

Additional relevant MeSH terms:
Stroke
Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes