- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03149835
NIV Reduces CBF in COPD Patients Without Cognitive Function
Acute Non-invasive Ventilation Reduces Cerebral Blood Flow in COPD Patients and Healthy Controls Without Effects on Cognitive Function
Study Overview
Status
Intervention / Treatment
Detailed Description
Nine COPD patients were screened from the Respiration Laboratory (RespLab) of Federal University of Ceará, and twelve sedentary controls from the general population were also assessed. All patients were under stable medical treatment at least two months, and COPD diagnosis was made according to GOLD guidelines. Patients were excluded if they had heart disease, arterial hypertension, other debilitating pulmonary or non-pulmonary diseases, depression, preexisting psychiatric or neurologic disorders, stroke, motor impairment, visual or hearing disabilities, mini-mental scale examination score below 20 points, and any disease that could influence the effectiveness of NIV application or the performance of cognitive tests. The control group consisted of healthy and nonsmoking volunteers.
After study enrollment, 15 days before the performance of the experimental protocol, patients performed neurocognitive tests (Digit Span Test, Digit Symbol-Coding, Corsi Block-tapping, Trail Making Test A and B and Stroop Test) and NIV adaptation. Pulmonary function (spirometry) was measured in all subjects after a thorough medical history and physical examination. Before initiating the protocol, patients were asked about discomfort related to NIV or any aspect of the experiment. CBF, capnometry, arterial blood gases (ABG) and neurocognitive tests were performed before, during and after NIV.
CBF was measured by transcranial Doppler by mean of LMCAFV immediately before NIV, during NIV at 5, 30 and 60 minutes and after NIV removal at 5 and 30 minutes. ABG were collected immediately before the experiment, after one hour of NIV breathing and 30 minutes after NIV discontinuation. Respiratory rate (RR), tidal volume (VT), oxygen saturation by pulse oximetry (SpO2), heart rate (HR), minute ventilation (VE) and mean systemic arterial blood pressure (MAP) were continuously measured by a multiparameter monitor (Dixtal DX-2010™, Dixtal, Manaus, Brazil) both on spontaneous respiration and NIV.
Subjects were tested in the morning and investigated while awake and at the supine position, throughout the experiment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients were under stable medical treatment at least two months
- COPD diagnosis was made according to GOLD guidelines
Exclusion Criteria:
- heart disease, arterial hypertension, other debilitating pulmonary or non-pulmonary diseases, depression, preexisting psychiatric or neurologic disorders, stroke, motor impairment, visual or hearing disabilities, mini-mental scale examination score bellow 20 points, and any disease that could influence the effectiveness of NIV application or the performance of cognitive tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: COPD
After study enrollment, 15 days before the performance of the experimental protocol, patients performed neurocognitive tests (Digit Span Test, Digit Symbol-Coding, Corsi Block-tapping, Trail Making Test A and B and Stroop Test) and NIV adaptation. Pulmonary function (spirometry) was measured in all subjects after a thorough medical history and physical examination. Before initiating the protocol, patients were asked about discomfort related to NIV or any aspect of the experiment. CBF was measured by transcranial Doppler by mean of LMCAFV immediately before NIV, during NIV at 5, 30 and 60 minutes and after NIV removal at 5 and 30 minutes. ABG were collected immediately before the experiment, after one hour of NIV breathing and 30 minutes after NIV discontinuation. |
NIV was provided by BiPAP-Vision™ ventilator (Philips Respironics Inc, Murrysville, PA, USA) set at the BIPAP mode and applied by a nasal mask, with room air, for 60 minutes.
Volunteers were studied during the application of NIV (inspiratory pressure of 14cmH2O and expiratory pressure of 4cmH2O), with a pressure support of 10cmH2O and without oxygen support (FIO2 0.21).
These pressure levels were chosen based on the current practice of NIV in the intensive care setting.
|
EXPERIMENTAL: Healthy Control
After study enrollment, 15 days before the performance of the experimental protocol, patients performed neurocognitive tests (Digit Span Test, Digit Symbol-Coding, Corsi Block-tapping, Trail Making Test A and B and Stroop Test) and NIV adaptation. Pulmonary function (spirometry) was measured in all subjects after a thorough medical history and physical examination. CBF was measured by transcranial Doppler by mean of LMCAFV immediately before NIV, during NIV at 5, 30 and 60 minutes and after NIV removal at 5 and 30 minutes. ABG were collected immediately before the experiment, after one hour of NIV breathing and 30 minutes after NIV discontinuation. |
NIV was provided by BiPAP-Vision™ ventilator (Philips Respironics Inc, Murrysville, PA, USA) set at the BIPAP mode and applied by a nasal mask, with room air, for 60 minutes.
Volunteers were studied during the application of NIV (inspiratory pressure of 14cmH2O and expiratory pressure of 4cmH2O), with a pressure support of 10cmH2O and without oxygen support (FIO2 0.21).
These pressure levels were chosen based on the current practice of NIV in the intensive care setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Function
Time Frame: Neurocognitive tests were applied after 60 min of NIV
|
Change from baseline in a neuropsychological test was performed after 60 min of NIV to evaluate cognitive dysfunction.
|
Neurocognitive tests were applied after 60 min of NIV
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral blood flow
Time Frame: Cerebral blood flow were tested after 60 min of NIV
|
A 2 MHz pulsed Transcranial Doppler (TCD) ultrasound Doppler-boxTM DLWTM Doppler system device (Compumedics DLWTM Doppler Company, Germany) was used to measure the change from baseline on left MCAFV (LMCAFV). The ultrasound probe was placed over the left temporal bone, just above the zygomatic arch (temporal window) to obtain LMCAF. |
Cerebral blood flow were tested after 60 min of NIV
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 021.04.07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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