Effect of Oxygen Supplementation on Cerebral Oxygenation, Symptoms and Performance During STST in COPD Patients

General Hospital of Thessaloniki "George Papanikolaou"

Status: Active, not recruiting

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: medical air; Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT07024914

GeorgePH39/16-01-2019

Details and patient eligibility

About

It is a randomised, single-blind trial of the effect of acute oxygen supplementation on cerebral oxygenation during the 30 sec Sit-To-Stand Test (STST) in chronic obstructive pulmonary disease patients, without resting hypoxemia. After an initial clinical assessment, patients preform the 30sec STST under near-infrared spectroscopy, a non invasive technique which assesses cerebral oxygenation at the prefrontal lobe. Measurements are performed twice, under oxygen supplementation or medical air, in a random order, and the patients are be blinded to the treatment (oxygen or medical air) given.

Enrollment: 25 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. clinical diagnosis of COPD, based on smoking history of at least 100 cigarettes and post bronchodilation forced expiratory volume (FEV1) to forced vital capacity (FVC) ratio <0.7, and 2) resting arterial oxygen partial pressure >60 mmHg, according to recent (within a week) arterial blood gases assessment.

Exclusion criteria

1. recent COPD exacerbation (as indicated by deterioration of respiratory symptoms, hospital admission and/or change in medication within the previous month), 2) history of specific balance problems (i.e., diagnosed neurological or vestibular disorder), 3) spinal surgery, and 4) lower limb musculoskeletal problems (i.e., surgery, injury or pathology at hip, knee, ankle or foot)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Supplementation of oxygen during the 30 sec Sit to Stand Test in patients with COPD

Active Comparator group

Description:

Oxygen supplementation via nasal cannula at a rate of 3 lit/min

Treatment:

Drug: Oxygen

Supplementation of medical air during the 30 sec Sit to Stand Test in patients with COPD

Sham Comparator group

Description:

Medical air supplementation via nasal cannula at a rate of 3 lit/min

Treatment:

Drug: medical air