Trial document




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  DRKS00004931

Trial Description

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Title

"Medical Vulnerability": Impact of hospital room cooling on vulnerable patients with lung disease during periods of extreme weather (UCaHS)

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Trial Acronym

UCaHS

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URL of the Trial

http://www.ucahs.org

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Brief Summary in Lay Language

The aim of the project “Medical vulnerability” is the identification of physiological parameters indicating an increased vulnerability (sensitivity and exposure) of patients with a chronic lung disease to heat stress and heat-related disease worsening. Our research focuses on the impact of heat stress on vulnerable patients at home as well as during hospitalization. For this, patient rooms will be equipped with special room-cooling units and the duration of hospitalization will be analyzed.

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Brief Summary in Scientific Language

The influence of heat stress on vulnerable patients will be examined by evaluating the length of stay, physiological parameters, symptom scores, fluid intake, and daily step counts.

Patients suffering from chronic illness are sensible to heat stress. This is a problem during a hospitalization as most German hospitals lack an air conditioning. Therefore, the effect of the indoor climate on the recuperation of these patients has to be investigated.

In this randomized clinical trial, the effects of air conditioned hospital rooms on the clinical outcome of patients will be examined.

Primary study aim:

To evaluate if patient rooms equipped with an additional air cooling system will expediate the recovery of patients and thereby reduce the patients' length of stay.

Intervention:

For the climatization (air-conditioning) of the patient rooms, water cooling systems will be installed to regulate the temperature. Patients will be randomized between a radiant cooling room (intervention group) and a room without a cooling system (control group).

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Organizational Data

  •   DRKS00004931
  •   2013/04/26
  •   [---]*
  •   yes
  •   Approved
  •   EA1/279/11, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1145-8079 
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Health Condition or Problem studied

  •   J44 -  Other chronic obstructive pulmonary disease
  •   J45 -  Asthma
  •   J46 -  Status asthmaticus
  •   I27.0 -  Primary pulmonary hypertension
  •   J84.1 -  Other interstitial pulmonary diseases with fibrosis
  •   J12 -  Viral pneumonia, not elsewhere classified
  •   J13 -  Pneumonia due to Streptococcus pneumoniae
  •   J14 -  Pneumonia due to Haemophilus influenzae
  •   J15 -  Bacterial pneumonia, not elsewhere classified
  •   J16 -  Pneumonia due to other infectious organisms, not elsewhere classified
  •   J17 -  Pneumonia in diseases classified elsewhere
  •   J18 -  Pneumonia, organism unspecified
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Interventions/Observational Groups

  •   Intervention Group - Vulnerable patients will be assigned to a patient room with radiant cooling
  •   Control Group - Vulnerable patients will be distributed to a patient room without radiant cooling
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Total length of hospital stay (days)

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Secondary Outcome

1. Score COPD Assessment Test (CAT)
2. Score Modified British Medical Research Council Questionnaire for Dyspnoea (mMRC)
3. Body weight
4. Body temperature
5. Oxygen saturation
6. Heart rate
7. Blood pressure
8. Fluid intake
9. Step count (measurement of daily activity)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/06/01
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   no maximum age
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Additional Inclusion Criteria

• COPD
• Asthma
• Pneumonia
• Lung fibrosis
• Pulmonary hypertension

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Exclusion Criteria

• Malignant disease (life expectancy <6 months)
• Necessity of intensive care (respiratory pump failure, hypercapnia >70mmHg, coma, hypoxemia <50mmHg, acidosis pH <7,35, circulatory insufficiency)
• Instable coronary disease
• Liver disease (Child-Pugh class C)
• Kidney disease (glomerular filtration rate ≤29 mL/min/1.73m²)
• Patient awaits lung transplantation
• Missing or withdrawn consent
• Inability to fulfil the testing and examination procedures
• Room change before discharge

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Addresses

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    • Charité Universitätsmedizin Berlin, Med. Klinik m. S Infektiologie und Pneumologie, Arbeitsbereich Ambulante Pneumologie
    • Mr.  Prof. Dr. med.  Christian   Witt 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin, Med. Klinik m. S Infektiologie und Pneumologie, Arbeitsbereich Ambulante Pneumologie
    • Mr.  Prof. Dr. med.  Christian  Witt 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Universitätsmedizin Berlin, Med. Klinik m. S Infektiologie und Pneumologie, Arbeitsbereich Ambulante Pneumologie
    • Mr.  Prof. Dr. med.  Chistian  Witt 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.