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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03835741
Other study ID # 21641
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 17, 2018
Est. completion date June 2026

Study information

Verified date June 2024
Source Laval University
Contact François Lellouche
Phone 4186568711
Email francois.lellouche@criucpq.ulaval.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration.


Description:

The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device) can reduce the hospital length of stay for acute exacerbation of COPD with comparison of manual oxygen titration. Patients with severe acute exacerbation of COPD requiring hospitalization will be included in this randomized controlled study and will be managed with either manual oxygen titration or automated oxygen titration (FreeO2 arm). The impact on the hospital length of stay will be evaluated.


Recruitment information / eligibility

Status Recruiting
Enrollment 102
Est. completion date June 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - COPD or suspected COPD ( Age>40, active or smoking history > 10pack/years), - - Acute exacerbation (increasing dyspnea recently) - One or more of the following criteria: increased sputum, modification of sputum purulence,increased dyspnea, - Moderate oxygen therapy: Oxygen flow < 8 lpm (or FiO2 < 0.60) to maintain a SpO2 >or = 92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow to maintain SpO2 > or = 92%) Exclusion Criteria: - Patient refusal - COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac pulmonary edema, pneumothorax or sedative overdose - No SpO2 signal - Encephalopathy score > 2 - Delirium - Other respiratory support needed (intubation or NIV) - Patient on withdrawal life support - Advance neoplasia (palliative stage) or terminal respiratory distress - Unavailability of FreeO2 device at the randomisation - Non optimal patient collaboration

Study Design


Related Conditions & MeSH terms


Intervention

Device:
FreeO2
an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
Other:
manual titration
a manual adjustment of oxygen during patient hospitalisation by hospital staff

Locations

Country Name City State
Canada Institut Universitaire de Cardiologie et de Pneumologie de Québec Quebec

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Arterial or Capillary blood gaz evolution Evaluation of the rate of respiratory acidosis (pH<7.35 and PaCO2>45mmHg) During hospital stay - From hospital admission until hospital discharge (around one week expected)
Other Hospital Readmission rate after hospital discharge Rate of hospital readmission after initial hospital discharge Until day 90 after study inclusion
Primary Hospital length of stay Duration of the hospital length of stay From hospital admission until hospital discharge (around one week expected)
Secondary ICU transfer The rate of ICU admission during hospital stay During hospital stay : from hospital admission until hospital discharge (around one week expected)
Secondary Oxygen administration duration The number of days patient receive oxygen supplementation During hospital stay : from hospital admission until hospital discharge (around one week expected)
Secondary Non invasive or invasive mechanic ventilation rate use The rate of NIV use during length of stay in hospital During hospital stay: from hospital admission until hospital discharge (around one week expected)
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