Interstitial Pneumonia, Lung Cancer, Sarcoidosis
Conditions
Brief summary
After randomization, the subjects undergo flexible bronchoscopy either with fractionated propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate, oxygen saturation, and oxygen requirement are measured continuously during the procedure and thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted continuously during and after the procedure.
Detailed description
In daily clinical praxis, propofol sedation is given manually in repeated doses (fractionated) by a specially-trained nurse in attendance of the bronchoscopist. But, fractionated propofol administration (FPA) may lead to oversedation and enhanced side effects (oxygen desaturation and arterial hypotension), as a stable plasma concentration of propofol is not maintainable. In contrast to FPA, continuous infusions of propofol are commonly used to induce and maintain long-term sedation in intensive care units and general anesthesia. Recently, continuous propofol infusion for sedation in bronchoscopy has been shown comparable to FPA in terms of safety and efficacy. Generally, infusion devices can be manually controlled (MCI) or target-controlled (TCI). In the latter, the physician sets a target blood concentration and the computerized infusion device makes the necessary changes to the infusion rate. The objective of this study is to compare propofol TCI with FPA in flexible bronchoscopy concerning patient safety and sedation quality.
Interventions
DEVICEFlexible bronchoscopy in moderate sedation
Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;
DEVICEOxygen saturation
Continuous measurement of oxygen saturation;
DEVICEBlood pressure
Measurement of non-invasive blood pressure every 3 minutes
DEVICEPropofol dosage
Report of dose adjustments und cumulative propofol dosage;
DEVICERecovery time after bronchoscopy
Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)
Sponsors
B. Braun Melsungen AG
Daniel Franzen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial oxygen saturation | During bronchoscopy | From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of an oxygen desaturation of > 4% from baseline | During bronchoscopy | From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes |
| Number of occasions with a systolic blood pressure < 90 mmHg during bronchoscopy, maximum oxygen requirement, | During bronchoscopy | From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes |
| Number of occasions with recorded an oxygen saturation of < 90% | During bronchoscopy | From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes |
| Cumulative propofol dose | At end of bronchoscopy | At time point when bronchoscope is removed (on average after 45 minutes) |
| Recovery time after bronchoscopy | During 2 hours after bronchoscopy | — |
| Frequency of dose adjustments | During bronchoscopy | From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes |
Countries
Switzerland
Outcome results
None listed