Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop

COPD Exacerbation Clinical Trial

— FreeO2 HypHop  

Official title:

Reduction of Length of Stay by Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03835741
• Other study ID #: 21641
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: June 2025

Study information

• Verified date: April 2023
• Source: Laval University
• Contact: François Lellouche
• Phone: 4186568711
• Email: francois.lellouche[@]criucpq.ulaval.ca
• Is FDA regulated: No
• 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 2025
• Est. primary completion date: December 2024
• 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

Related Conditions & MeSH terms

• COPD Exacerbation
• Hyperoxia
• Hypoxemia
• Hypoxia
• Hypoxic Respiratory Failure
• Oxygen Toxicity
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

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)