NIV Reduces CBF in COPD Patients Without Cognitive Function

NCT03149835 | Completed DMC

• 1 other identifier: 021.04.07
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cognitive Function

  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 Outcomes (1)

• Cerebral blood flow

  Cerebral blood flow were tested after 60 min of NIV

Study Arms (2)

COPD

EXPERIMENTAL

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.

Other: Non-invasive ventilation

Healthy Control

EXPERIMENTAL

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.

Other: Non-invasive ventilation

Interventions

Non-invasive ventilation 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.

COPD; Healthy Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients were under stable medical treatment at least two months
• COPD diagnosis was made according to GOLD guidelines

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Ceara: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cognitive Dysfunction

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 11, 2017
• Study Start: May 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: May 31, 2011
• Last Updated: May 11, 2017

Record last verified: 2007-04

Data Sharing

• IPD Sharing: Will not share