Vil iltbehandling til en iltmætning på 88-92% sammenlignet med iltbehandling til en iltmætning på >94% reducere dødeligheden for patienter med kronisk obstruktiv lungesygdom med akut forværring? - et randomiseret klinisk forsøg

Phase 1

• Conditions: Acute COPD Exacerbation; MedDRA version: 21.1Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-002498-80-DK
• Lead Sponsor: Mikkel Brabrand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-08
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 415

Inclusion Criteria

Patients eligible for the trial must comply with the following at randomization:
1.age 18 years or older
2.ability to give informed consent
3.previously diagnosed COPD (either confirmed diagnosis at prior hospital contact or from their general practitioner or confirmed diagnosis by the treating physician in the emergency department (verified by use of relevant medication))
4.admitted with acute exacerbation (acute and worsened shortness of breath) of COPD
5.requiring oxygen treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 415
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 415

Exclusion Criteria

1.Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes
2.Expected total length of stay in hospital < 12 hours
3.Planned transfer to another hospital within 12 hours
4.Unwilling to have repeated arterial blood gas analyses within the first 12 hours
5.Patients judged terminal by treating physician in the emergency department
6.Non-residents of the particular country
7.Expected impossible follow-up
8.Fertile women (<50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
9.Prior participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified