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Early Signs of Altitude Illness in Patients With COPD

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ClinicalTrials.gov Identifier: NCT03957759
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date May 16, 2019
First Posted Date May 21, 2019
Last Update Posted Date August 16, 2019
Actual Study Start Date May 20, 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2019)
Diagnostic accurarcy measures of structured self-monitoring [ Time Frame: Day 1 to 3 at 3100m ]
Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the the curve. The diagnostic performance will be compared statistically using c-statistics against the reference test. Reference test will be the occurence of altitude-related illness defined as the following:
  • AMS defined by the Lake Louise questionnaire score or with AMSc score
  • severe hypoxemia (SpO2 <80% at rest >30 min; or SpO2 <75% at rest >15 min;
  • intercurrent illness that cannot be relieved by simple measures such as paracetamol 3x500 mg/day, inhalation of bronchodilators.
  • dyspnea or discomfort at rest requiring treatment with oxygen
  • chest pain or ECG signs of cardiac ischemia
  • severe hypertension: systolic blood pressure >200 mmHg, diastolic blood pressure >110 mmHg
  • new onset neurologic impairment
  • Any condition that requires study withdrawal according to the decision of the independent physician
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03957759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 16, 2019)
  • Acute mountain sickness severity assessed by the Lake Louise score [ Time Frame: Day 1 to 3 at 3100m ]
    The severity of acute mountain sickness will be assessed by the Lake Louise questionnaire. The severity will be calculated when the presence of headache and at least one of the following symptoms is present: gastrointestinal upset, fatigue or weakness and dizziness or lightheadedness. Each of the four questions is asked with the corresponding 0 to 3 rating of the response (0 = Not present, 1 = mild, 2 = moderate, 3 = severe). The sum of the responses on these questions is then calculated, resulting in the AMS severity.
  • Altitude-related illness, incidence [ Time Frame: Day 1 to 3 at 3100m ]
    Incidence of ARI during the stay at 3100 m. ARI is defined as the following:
    • AMS defined by the Lake Louise questionnaire score or with AMSc score
    • severe hypoxemia (SpO2 <80% at rest >30 min; or SpO2 <75% at rest >15 min;
    • intercurrent illness that cannot be relieved by simple measures such as paracetamol 3x500 mg/day, inhalation of bronchodilators.
    • dyspnea or discomfort at rest requiring treatment with oxygen
    • chest pain or ECG signs of cardiac ischemia
    • severe hypertension: systolic blood pressure >200 mmHg, diastolic blood pressure >110 mmHg
    • new onset neurologic impairment
    • Any condition that requires study withdrawal according to the decision of the independent physician
  • Spirometric measurement of forced expiratory volume in one second [ Time Frame: Day 2 at 760 and 3100m ]
    Altitude-induced change in the forced expiratory volume in one between 760 and 3100m
  • Arterial partial pressure of oxygen [ Time Frame: Day 2 at 760 and 3100m ]
    Altitude-induced change in arterial partial pressure of oxygen assessed by arterial blood gas puncture at 760 and 3100m
  • Six-minute walk distance in meters [ Time Frame: Day 2 at 760 and 3100m ]
    Altitude-induced change in the six-minute walk distance assessed by the six-minute walk test performed at 760 and 3100m
  • Changes in ST-Segment of the ECG during ergometry [ Time Frame: Day 1 at 760 and 3100m ]
    Altitude-induced change in the ST-Segment of the ECG assessed during a maximal ergometry test performed at 760 and 3100m
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Signs of Altitude Illness in Patients With COPD
Official Title Self-Monitoring for Early Signs of Altitude Illness in Patients With Chronic Obstructive Pulmonary Disease. A Diagnostic Test Accuracy Study.
Brief Summary This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel.
Detailed Description

This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel. After baseline evaluation at 760 m, patients will travel by bus within 3-5 h to the Tuja Ashu high altitude clinic at 3'100 m and stay there for 2 days. During this period, participants will perform SSM. They are instructed to report to study personnel if they fulfill predefined criteria for impeding altitude-related illness.

A planned interim analysis will be performed after the first year of the study or after completion of study by 80 participants, whichever comes first to allow any necessary adaptations of the sample size or terminate the study early for futility or high accuracy of the index test.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with COPD, FEV1 40-80% predicted living at low altitude.
Condition Chronic Obstructive Pulmonary Disease
Intervention Diagnostic Test: Structured self-monitoring during an altitude ascent and stay at high altitude
Structured self-monitoring by a symptom checklist in combination with a pulse oximeter worn at the wrist in lowlanders with COPD ascending from low altitude (760m) to high altitude (3100m).
Study Groups/Cohorts COPD patients
Intervention: Diagnostic Test: Structured self-monitoring during an altitude ascent and stay at high altitude
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 16, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria

  • Male and female patients, age 18-75 yrs.
  • COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92%, PaCO2 <6 kPa at 760 m.
  • Born, raised and currently living at low altitude (<800 m).
  • Written informed consent.

Exclusion criteria

  • COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1 <40% predicted; oxygen saturation on room air <92% or hypercapnia at 760 m).
  • Other lung disease or disorder of control of breathing
  • Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Konrad E Bloch, MD +41442553828 konrad.bloch@usz.ch
Contact: Michael Furian, PhD +41442553828 michael.furian@usz.ch
Listed Location Countries Kyrgyzstan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03957759
Other Study ID Numbers 01-8/464-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Investigators
Study Chair: Konrad E Bloch, MD University of Zurich
Study Director: Talant M Sooronbaev, MD National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
PRS Account University of Zurich
Verification Date August 2019