Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-28 @ 11:26 AM
Study NCT ID:
NCT04223050
Status:
UNKNOWN
Last Update Posted:
2022-11-01
First Post:
2020-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C041364', 'term': 'nitrox'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization will be performed as block randomization with a 1:1 allocation using an electronic randomization system accessible via the internet (REDCap via OPEN at the University of Southern Denmark). The participants will be randomized electronically bedside by the study representatives.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 415}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2020-01-07', 'studyFirstSubmitQcDate': '2020-01-07', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day all-cause mortality', 'timeFrame': '30 days', 'description': 'Data is extracted from the Danish national registries.'}], 'secondaryOutcomes': [{'measure': '7-day all-cause mortality', 'timeFrame': '7 days', 'description': 'Data is extracted from the Danish national registries.'}, {'measure': 'Non-invasive ventilation', 'timeFrame': '12 hours', 'description': 'The Medical records will be reviewed for documentation on if the patient has been on non-invasive ventilation. This will be reported as proportion of patients on NIV'}, {'measure': 'Intubation', 'timeFrame': '12 hours', 'description': 'The Medical records will be reviewed for documentation on if the patient has been intubated. This will be reported as proportion of patients intubated'}, {'measure': 'Intensive care admission', 'timeFrame': '1 day', 'description': 'Extracted from the hospital records.'}, {'measure': 'Overall length of hospital stay', 'timeFrame': '10 days', 'description': 'Time calculated from the hospital records'}, {'measure': 'Respiratory acidosis', 'timeFrame': '12 hours', 'description': 'Measured as an arterial blood gas analysis with pH \\> 7.35 and hypercapnia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Oxygen treatment', 'Mortality'], 'conditions': ['COPD Exacerbation', 'Chronic Obstructive Pulmonary Disease Exacerbation']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is a common disorder that affects approximately 400,000 Danish citizens. About 3,000-3,500 Danes die yearly because of the disorder, and the costs associated with hospital admissions are estimated to be 535 million Danish kroner (DKK). Patients with COPD risk a worsening of their disorder, and in most cases, this will require hospitalization. One of the used treatments is providing oxygen to the patients via e.g. masks. The recommendations on oxygen treatment are currently based on a study from 2010 where 37% of the participants in this study did not receive the intended treatment, which may have had massive effects on the results. It is worrying that no other studies have shown which oxygen treatment is safest for the patients. As such, we deem it important to study how best to treat the patients.\n\nOur study is of high clinical relevance as hospitals receive patients with worsening of COPD daily. We need more, better data regarding the oxygen treatment of our patients, in order to provide our patients with the best possible care. The purpose of our study is thus to determine which oxygen treatment is best for patients with acute worsening of COPD symptoms. We will use a prospective, randomized controlled open-label trial. We will use two treatments: Treatment 1 is giving oxygen to the patient to reach a peripheral oxygen saturation of above 94%. Treatment 2 is giving oxygen to reach a peripheral oxygen saturation of between 88% and 92%.\n\nOur primary outcome is 30-day all-cause mortality, with secondary outcomes being 7-day all-cause mortality, need for non-invasive ventilation, intubation or intensive care admission, over-all length of hospital stay and respiratory acidosis.\n\nWe believe that a lower oxygen saturation percentage may be superior as one study (Austin et al., 2010) showed a lower mortality rate in the group of patients that had a lower peripheral oxygen saturation. Additionally, the risk of respiratory acidosis and hypercapnia were lower. We wish to perform our study in the hospital sector as this study was performed in the prehospital sector and thus their results cannot be translated directly.', 'detailedDescription': 'Please refer to the full protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years or older\n* ability to give informed consent\n* 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))\n* admitted with acute exacerbation (acute and worsened shortness of breath) of COPD\n* requiring oxygen treatment\n\nExclusion Criteria:\n\n* Instability at arrival requiring immediate lifesaving treatment, e.g. intubation or non-invasive ventilation, within the first 30 minutes\n* Expected total length of stay in hospital \\< 12 hours\n* Planned transfer to another hospital within 12 hours\n* Unwilling to have repeated arterial blood gas analyses within the first 12 hours\n* Patients judged terminal by treating physician in the emergency department\n* Non-residents of the particular country\n* Expected impossible follow-up\n* Fertile women (\\<50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG\n* Prior participation in the study'}, 'identificationModule': {'nctId': 'NCT04223050', 'acronym': 'O2flow-COPD', 'briefTitle': 'Comparing Mortality for Low vs High Peripheral Oxygen Saturation in COPD-patients With Acute Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'Esbjerg Hospital - University Hospital of Southern Denmark'}, 'officialTitle': 'Will Titrated Oxygen Flow to a Peripheral Oxygen Saturation of 88-92% Compared With Oxygen Flow to a Saturation >94% Reduce Mortality in Chronic Obstructive Pulmonary Disease Patients With Acute Exacerbation? - a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2019-002498-80'}, 'secondaryIdInfos': [{'id': '19/4298', 'type': 'REGISTRY', 'domain': 'Region of Southern Denmark'}, {'id': '2019-002498-80', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High oxygen saturation', 'description': 'Peripheral oxygen saturation level \\>94%', 'interventionNames': ['Drug: Oxygen gas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low oxygen saturation', 'description': 'Peripheral oxygen saturation level 88-92%', 'interventionNames': ['Drug: Oxygen gas']}], 'interventions': [{'name': 'Oxygen gas', 'type': 'DRUG', 'description': 'Administering oxygen to achieve the desired peripheral oxygen saturation', 'armGroupLabels': ['High oxygen saturation', 'Low oxygen saturation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6700', 'city': 'Esbjerg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mikkel Brabrand, MD PhD', 'role': 'CONTACT', 'email': 'mikkel.brabrand@rsyd.dk', 'phone': '+45 7918 5934'}], 'facility': 'Sydvestjysk Sygehus', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '4300', 'city': 'Holbæk', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Peter Hallas, MD', 'role': 'CONTACT', 'email': 'phaa@regionsjaelland.dk', 'phone': '59 48 38 01'}], 'facility': 'Holbæk Sygehus', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}, {'zip': '6000', 'city': 'Kolding', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Simon Thorgaard-Rasmussen, MD', 'role': 'CONTACT', 'email': 'Simon.Thorgaard-Rasmussen@rsyd.dk'}], 'facility': 'Sygehus Lillebælt, Kolding', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}, {'zip': '5000', 'city': 'Odense', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Sune Laugesen, MD', 'role': 'CONTACT', 'email': 'Sune.Laugesen@rsyd.dk'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Mikkel Brabrand, MD PhD', 'role': 'CONTACT', 'email': 'mikkel.brabrand@rsyd.dk', 'phone': '+45 7918 5934'}, {'name': 'Line E. Lilholm Laugesen, MScPH', 'role': 'CONTACT', 'email': 'Line.Emilie.Lilholm.Laugesen@rsyd.dk', 'phone': '+45 7918 5934'}], 'overallOfficials': [{'name': 'Peter Hallas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Holbaek Sygehus'}, {'name': 'Sune Laugesen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}, {'name': 'Simon Thorgaard-Rasmussen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sygehus Lillebælt, Kolding'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '(Indsæt senere)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esbjerg Hospital - University Hospital of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Holbaek Sygehus', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Sygehus Lillebaelt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}