NIV Reduces CBF in COPD Patients Without Cognitive Function

May 9, 2017 updated by: Marcelo Alcantara Holanda, Universidade Federal do Ceará

Acute Non-invasive Ventilation Reduces Cerebral Blood Flow in COPD Patients and Healthy Controls Without Effects on Cognitive Function

Objectives: Investigate the acute NIV effects on CBF and cognitive functions in COPD patients. Methods: Nine non-hypercapnic stable COPD subjects (FEV1/FVC < lower limit of normal) and twelve healthy controls were enrolled. CBF (transcranial Doppler), cognitive functions, respiratory and cardiovascular response were tested at baseline, during and after non-invasive ventilation.

Study Overview

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

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2007

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 31, 2011

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (ACTUAL)

May 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

April 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • 021.04.07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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