Northern Survey on Therapeutic Oxygen Prescription (NONSTOP)

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

Study Overview

• Status: Unknown
• Conditions: Oxygen Toxicity
• Intervention / Treatment: Other: 17 items questionaire

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Thomas Fühner, PD Dr. med.; Phone Number: 431 +49 531595; Email: fühner.thomas@mh-hannover.de
• Study Contact Backup: Name: Heiko Golpon, PD Dr. med.; Phone Number: 6553 +49 511 532; Email: golpon.heiko@mh-hannover.de

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Recruiting
    • Department of Respiratory Medicine, Medizinische Hochschule Hannover
    • Principal Investigator: Jens Gottlieb, MD
    • Contact: Jens Gottlieb, MD; Phone Number: 3560 +49-511-532; Email: gottlieb.jens@mh-hannover.de
    • Sub-Investigator: Heiko Golpon, MD
  • Hannover, Germany, 30625
    • Recruiting
    • Dep. Respiratory Medicine, Hannover Medical School
    • Principal Investigator: Jens Gottlieb, MD
    • Contact: Thomas Fuehner, MD; Phone Number: +495115323505; Email: fuehner.thomas@mh-hannover.de
    • Contact: Jens Gottlieb, MD; Phone Number: +495115323505; Email: gottlieb.jens@mh-hannover.de
    • Principal Investigator: Thomas Fuehner, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients fulfilling the Inclusion criteria and not the exclusion criteria at 3 Centers in nothern Germany

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of indication of Long-term Oxygen therapy (LTOT)	Aim of this study is to observe the real-world handling with longterm Oxygen treatment in northern Germany	12 month

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Jens Gottlieb, Prof. Dr. med., Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Anticipated): June 20, 2021
• Study Completion (Anticipated): September 20, 2021

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Pneumo-O2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing of individual participants data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No