Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004257

Trial Description

start of 1:1-Block title

Title

Effectivity of different oxygen therapy devices in patients with chronic lung disease in the inflight environment: oxygen cylinders vs. oxygen concentrators

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The study is used for the verification of six oxygen supplying systems (portable oxygen concentrators) in patients with chronic obstructive pulmonary disease at an altitude of 2650 m. This altitude corresponds to the cabin pressure of commercial aircrafts. Therefore, the results of the study can be transferred to the suitability of the systems tested in an inflight environment.
Thus, patients should be informed of the efficiency and performance of certain systems.
The main objective of the study is the oxygenation of the patients, as measured by blood gases 30 min after administration of oxygen through the various tested systems.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

We selected patients with chronic obstructive lung disease (GOLD stage II/III) in a stable condition from our outpatient clinic. They were studied at the Schneefernerhaus at 2650 m. This altitude is comparable to the environment in an airplane at cruising altitude (2). The local ethics committee approved the study and written informed consent was obtained from all participants.
Baseline evaluation was performed in Munich at an altitude of 540 m and included medical history, spirometry, bodyplethysmography, oxygen saturation, heart rate and capillary blood gases from the arterialised ear lobe.
The patients were brought by cogwheel train to the altitude lab at 2650m, where they were connected to the reference oxygen system used by Lufthansa during air travel (WS120) delivering an equivalent of 2.8l O2/min via nasal cannula. After 30 min resting in supine position, blood gases were sampled from the arterialized ear lobe.
Then, each patient received oxygen via nasal cannula from one of the POCs. The oxygen delivery rate was chosen according to the results of the technical test to obtain approximately comparable delivery rates of 2.0 to 2.5 l O2/min. The devices were then changed in a random order. We obtained blood gas results and oxygen saturation data from each patient after a steady state period of 30 min with each device. To evaluate the improvement in oxygenation by the devices, each patient was also tested after exposure to room air for 30 min.
During the study period, patients were not allowed any exercise except for the walk to the bathroom, and measurements were only taken after at least 10 min of rest.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004257
  •   2012/07/20
  •   [---]*
  •   yes
  •   Approved
  •   274/09, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J44.9 -  Chronic obstructive pulmonary disease, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients mit COPD II/III according to GOLD are exposed in a random manner to six different oxygen delivering devices for 30 min:
    Arm 1: Freestyle (Airsep)
    During the study, exercise was not allowed and blood gases were drawn after 30 min of exposure with each devices or room air.
  •   Patients mit COPD II/III according to GOLD are exposed in a random manner to six different oxygen delivering devices for 30 min:
    Arm 2: XPO2 (Invacare)
    During the study, exercise was not allowed and blood gases were drawn after 30 min of exposure with each devices or room air.
  •   Patients mit COPD II/III according to GOLD are exposed in a random manner to six different oxygen delivering devices for 30 min:
    Arm 3: Inogen One (Inogen)
    During the study, exercise was not allowed and blood gases were drawn after 30 min of exposure with each devices or room air.
  •   Patients mit COPD II/III according to GOLD are exposed in a random manner to six different oxygen delivering devices for 30 min:
    Arm 4: EverGo (Philipps).
    During the study, exercise was not allowed and blood gases were drawn after 30 min of exposure with each devices or room air.
  •   Patients mit COPD II/III according to GOLD are exposed in a random manner to six different oxygen delivering devices for 30 min:
    Arm 5: Eclipse 3 (Sequal)
    During the study, exercise was not allowed and blood gases were drawn after 30 min of exposure with each devices or room air.
  •   Patients mit COPD II/III according to GOLD are exposed in a random manner to six different oxygen delivering devices for 30 min:
    Arm 6: WS120 (EMS).
    During the study, exercise was not allowed and blood gases were drawn after 30 min of exposure with each devices or room air.
  •   Patients mit COPD II/III according to GOLD are exposed in a random manner to six different oxygen delivering devices for 30 min:
    Arm 7: room air at 2650 m
    During the study, exercise was not allowed and blood gases were drawn after 30 min of exposure with each devices or room air.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Main study objective was the arterial oxygenation after 30 min of exposure with each of the tested devices or after room air at 2650 m. Oxygenation was evaluated by blood gases from the arterialised ear lobe (PaO2, partial oxygen pressure).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Oxygen saturation (SaO2) was measured by pulse oxymetrie after 30 min of exposure with one of the tested devices or with room air at 2650 m. Carbon dioxide partial pressure (PaCO2) was assessed together with the primary outcome (PaO2) by arterial blood gas measurement.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/07/01
  •   11
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

COPD Grade II / III according GOLD guidelines
stable phase of disease
living in Munich
subjective feeling that weather does influence the disease

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- concurrent severe disease (as dementia, carcinoma, right heart failure, stroke, myocardial infarction)
- continuous oxygen therapy
- high altitude fear
- reduced PaO2 < 60 mmHg
- increased PaCO2 > 50 mmHg
- patients with emphysema (intrathoracic gas volume larger 130 % predicted)

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Akademie für Flug- und Reisemedizin gGmbH
    • Lufthansabasis, FRA/PM
    • 60546  Frankfurt
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2011/07/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.