NIV Reduces CBF in COPD Patients Without Cognitive Function

NCT ID: NCT03149835

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-01
• Study Completion Date: 2011-05-31

Brief Summary

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.

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.

Conditions

COPD; Non-invasive Ventilation; Cognitive Impairment; Cerebral Blood Flow

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Non-invasive ventilation

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Non-invasive ventilation

Intervention Type: OTHER

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.

Interventions

Non-invasive ventilation

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal do Ceara

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Alcantara Holanda

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

021.04.07

Identifier Type: -

Identifier Source: org_study_id