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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2016 |
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Main ID: |
NCT02246023 |
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Date of registration:
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15/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy
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Scientific title:
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Target-controlled Versus Manually-controlled Propofol Sedation in Flexible Bronchoscopy. A Randomized Non-inferiority Trial. |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02246023 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Daniel Franzen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Pulmonology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects undergoing a planned, ambulatory flexible bronchoscopy (for transbronchial
lung biopsy or endobronchial ultrasound guided procedures) in moderate sedation, aged
between 18 and 85 years
Exclusion Criteria:
- History of solid organ or bone marrow transplantation with the use of an
immunosuppressive therapy
- HIV infection on anti-retroviral therapy
- Alcohol consumption more than two standard drinks per day
- Use of illicit drugs (heroin, opiates)
- Any contraindication to use propofol for sedation (e.g. allergy)
- Body mass index > 35 kg/m2
- Mental disorder preventing appropriate judgment concerning study participation
- Missing written patient's informed consent
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Interstitial Pneumonia
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Sarcoidosis
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Lung Cancer
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Intervention(s)
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Device: Recovery time after bronchoscopy
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Device: Oxygen saturation
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Device: Flexible bronchoscopy in moderate sedation
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Device: Blood pressure
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Device: Propofol dosage
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Primary Outcome(s)
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Mean arterial oxygen saturation
[Time Frame: During bronchoscopy]
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Secondary Outcome(s)
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Number of an oxygen desaturation of > 4% from baseline
[Time Frame: During bronchoscopy]
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Number of occasions with recorded an oxygen saturation of < 90%
[Time Frame: During bronchoscopy]
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Frequency of dose adjustments
[Time Frame: During bronchoscopy]
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Cumulative propofol dose
[Time Frame: At end of bronchoscopy]
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Number of occasions with a systolic blood pressure < 90 mmHg during bronchoscopy, maximum oxygen requirement,
[Time Frame: During bronchoscopy]
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Recovery time after bronchoscopy
[Time Frame: During 2 hours after bronchoscopy]
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Secondary ID(s)
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BronchoPropTCI
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SNCTP000000706
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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