Lung CancerPhase 4NCT02246023
Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy
A Phase 4 study testing Flexible bronchoscopy in moderate sedation, Oxygen saturation and Blood pressure in people with Lung Cancer and Sarcoidosis, run by Daniel Franzen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer, Sarcoidosis, Interstitial Pneumonia
- What is being tested?
- Flexible bronchoscopy in moderate sedation, Oxygen saturation and Blood pressure
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Target-controlled Versus Manually-controlled Propofol Sedation in Flexible Bronchoscopy. A Randomized Non-inferiority Trial.
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.
Read the 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.
- Conditions
- Lung Cancer, Sarcoidosis, Interstitial Pneumonia
- Being tested
- Flexible bronchoscopy in moderate sedation, Oxygen saturation, Blood pressure, Propofol dosage, Recovery time after bronchoscopy
- Medical subject headings
- Lung Neoplasms, Sarcoidosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible bronchoscopy in moderate sedationDevice
Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;
Oxygen saturationDevice
Continuous measurement of oxygen saturation;
Blood pressureDevice
Measurement of non-invasive blood pressure every 3 minutes
Propofol dosageDevice
Report of dose adjustments und cumulative propofol dosage;
Recovery time after bronchoscopyDevice
Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)
| Study group | Role | What they receive |
|---|---|---|
| Fractionated propofol administration | Active comparator | Flexible bronchoscopy in moderate sedation with fractionated propofol administrations: Patients receive an initial 20 mg of propofol, followed by a carefully titrated dose of10-20 mg propofol based on the clinical response.
Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy Receives: Device: Flexible bronchoscopy in moderate sedation; Device: Oxygen saturation; Device: Blood pressure; Device: Propofol dosage; Device: Recovery time after bronchoscopy |
| Propofol-TCI | Experimental | Flexible bronchoscopy in moderate sedation with TCI propofol perfusor:
Flexible bronchoscopy is started after reaching the initial targeted effect-site concentration (Ce) of 2.5 μg/mL using the Schnider pharmacokinetic model described elsewhere. Thereafter, Ce is adjusted by increments of 0.2 μg/mL depending on the clinical effect, in order to maintain the required level of sedation.
Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy The propofol-TCI perfusor is an active infusion system for fluid management. In the study, the Perfusor® Space of B. Braun AG, Melsungen is used exclusively. Receives: Device: Flexible bronchoscopy in moderate sedation; Device: Oxygen saturation; Device: Blood pressure; Device: Propofol dosage; Device: Recovery time after bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial oxygen saturation
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Measured: During bronchoscopy
Secondary outcomes (6)
Number of occasions with recorded an oxygen saturation of < 90%
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Measured: During bronchoscopy
Number of an oxygen desaturation of > 4% from baseline
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Measured: During bronchoscopy
Number of occasions with a systolic blood pressure < 90 mmHg during bronchoscopy, maximum oxygen requirement,
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Measured: During bronchoscopy
Frequency of dose adjustments
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
Measured: During bronchoscopy
Cumulative propofol dose
At time point when bronchoscope is removed (on average after 45 minutes)
Measured: At end of bronchoscopy
Recovery time after bronchoscopy
Measured: During 2 hours after bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Franzen
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Responsible party
- Sponsor-investigator, Daniel Franzen, University of Zurich
- Investigators
- Daniel Franzen, MD, Principal investigator, Division of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246023
- Sponsor's protocol ID
- BronchoPropTCI
- Other IDs
- SNCTP000000706
- Status last verified
- Jun 2015
- First submitted
- 15 Sep 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target-controlled Versus Manually-controlled Propofol Sedation in Flexible Bronchoscopy. A Randomized Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT02246023
- Acronym / sponsor ID
- BronchoPropTCI
- Conditions
- Lung Cancer, Sarcoidosis, Interstitial Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Daniel FranzenUniversity, hospital or other
- Collaborators
- B. Braun Melsungen AG
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractionated propofol administration | Active comparator | Device: Flexible bronchoscopy in moderate sedation, Device: Oxygen saturation, Device: Blood pressure, Device: Propofol dosage, Device: Recovery time after bronchoscopyFlexible bronchoscopy in moderate sedation with fractionated propofol administrations: Patients receive an initial 20 mg of propofol, followed by a carefully titrated dose of10-20 mg propofol based on the clinical response. Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy |
| Propofol-TCI | Experimental | Device: Flexible bronchoscopy in moderate sedation, Device: Oxygen saturation, Device: Blood pressure, Device: Propofol dosage, Device: Recovery time after bronchoscopyFlexible bronchoscopy in moderate sedation with TCI propofol perfusor: Flexible bronchoscopy is started after reaching the initial targeted effect-site concentration (Ce) of 2.5 μg/mL using the Schnider pharmacokinetic model described elsewhere. Thereafter, Ce is adjusted by increments of 0.2 μg/mL depending on the clinical effect, in order to maintain the required level of sedation. Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy The propofol-TCI perfusor is an active infusion system for fluid management. In the study, the Perfusor® Space of B. Braun AG, Melsungen is used exclusively. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible bronchoscopy in moderate sedationFlexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol; | Device | Fractionated propofol administration, Propofol-TCI |
| Oxygen saturationContinuous measurement of oxygen saturation; | Device | Fractionated propofol administration, Propofol-TCI |
| Blood pressureMeasurement of non-invasive blood pressure every 3 minutes | Device | Fractionated propofol administration, Propofol-TCI |
| Propofol dosageReport of dose adjustments und cumulative propofol dosage; | Device | Fractionated propofol administration, Propofol-TCI |
| Recovery time after bronchoscopyRecovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first) | Device | Fractionated propofol administration, Propofol-TCI |
Primary outcome
Mean arterial oxygen saturation
Time frame: During bronchoscopy
From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes
6 secondary outcomes
Number of occasions with recorded an oxygen saturation of < 90%
Time frame: During bronchoscopy
Number of an oxygen desaturation of > 4% from baseline
Time frame: During bronchoscopy
Number of occasions with a systolic blood pressure < 90 mmHg during bronchoscopy, maximum oxygen requirement,
Time frame: During bronchoscopy
Frequency of dose adjustments
Time frame: During bronchoscopy
Cumulative propofol dose
Time frame: At end of bronchoscopy
Recovery time after bronchoscopy
Time frame: During 2 hours after bronchoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Franzen, MD principal investigator
Division of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flexible bronchoscopy in moderate sedation, Oxygen saturation and Blood pressure in people with Lung Cancer and Sarcoidosis, run by Daniel Franzen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial oxygen saturation (time frame: During bronchoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.