Ignite Creation Date:
2024-05-05 @ 10:26 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01109355
Status:
COMPLETED
Last Update Posted:
2010-04-23
First Post:
2010-04-19
Brief Title:
Positive and Expiratory Pressure and Hemorrhagic Stroke
Sponsor:
Universidade Federal de Pernambuco
Organization:
Universidade Federal de Pernambuco
Study Overview
Official Title:
Effect of Positive End Expiratory Pressure on Cerebral Perfusion Pressure in Adult Patients With Hemorrhagic Stroke
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 brAll 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 8mlkg 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 brDuring 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 brThe 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 brAfter 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None