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Positive and Expiratory Pressure and Hemorrhagic Stroke

Primary Purpose

Stroke, Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
lung mechanics ventilatory
Hemodynamic and intracranial pressure
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring PEEP, Patients with hemorrhage stroke under mechanical ventilation

Eligibility Criteria

42 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Português

Outcomes

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).

Full Information

First Posted
April 19, 2010
Last Updated
April 22, 2010
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT01109355
Brief Title
Positive and Expiratory Pressure and Hemorrhagic Stroke
Official Title
Effect of Positive End Expiratory Pressure on Cerebral Perfusion Pressure in Adult Patients With Hemorrhagic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemorrhage
Keywords
PEEP, Patients with hemorrhage stroke under mechanical ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
lung mechanics ventilatory
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hemodynamic and intracranial pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of intracranial pressure
Description
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 Measure Information:
Title
Effect of different values of PEEP on lung mechanics
Description
- 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.
Title
Effect of different PEEP levels on aspects hemodynamic
Description
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Campelo
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Português
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
15069242
Citation
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.
Results Reference
result
PubMed Identifier
11022062
Citation
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.
Results Reference
result

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Positive and Expiratory Pressure and Hemorrhagic Stroke

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