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Northern Survey on Therapeutic Oxygen Prescription (NONSTOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937622
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hannover Medical School

Brief Summary:
This is a prospective multicenter observational trial. Included patients and attending physician complete a standardized questionnaire.

Condition or disease Intervention/treatment
Oxygen Toxicity Other: 17 items questionaire

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Northern Survey on Therapeutic Oxygen Prescription
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : June 20, 2021
Estimated Study Completion Date : September 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy


Intervention Details:
  • Other: 17 items questionaire
    This is a prospective multicenter observational trial. Included patients and attending physician complete a standardised questionnaire.


Primary Outcome Measures :
  1. Validation of indication of Long-term Oxygen therapy (LTOT) [ Time Frame: 12 month ]
    Aim of this study is to observe the real-world handling with longterm Oxygen treatment in northern Germany



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients fulfilling the Inclusion criteria and not the exclusion criteria at 3 Centers in nothern Germany
Criteria

Inclusion Criteria:

  • Patients with chronic lung disease, age > 18 years
  • Established domiciliary LTOT > 4 weeks
  • Scheduled for control of oxygen therapy with arterial/capillary

Exclusion Criteria:

  • No informed consent
  • Pulmonary exacerbation within the last 2 weeks
  • Signs of heart failure (edema, congestion)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937622


Contacts
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Contact: Thomas Fühner, PD Dr. med. +49 531595 ext 431 fühner.thomas@mh-hannover.de
Contact: Heiko Golpon, PD Dr. med. +49 511 532 ext 6553 golpon.heiko@mh-hannover.de

Locations
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Germany
Dep. Respiratory Medicine, Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Thomas Fuehner, MD    +495115323505    fuehner.thomas@mh-hannover.de   
Contact: Jens Gottlieb, MD    +495115323505    gottlieb.jens@mh-hannover.de   
Principal Investigator: Thomas Fuehner, MD         
Principal Investigator: Jens Gottlieb, MD         
Department of Respiratory Medicine, Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Jens Gottlieb, MD    +49-511-532 ext 3560    gottlieb.jens@mh-hannover.de   
Principal Investigator: Jens Gottlieb, MD         
Sub-Investigator: Heiko Golpon, MD         
Sponsors and Collaborators
Hannover Medical School
Investigators
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Principal Investigator: Jens Gottlieb, Prof. Dr. med. Hannover Medical School
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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT03937622    
Other Study ID Numbers: Pneumo-O2
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing of individual participants data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No