Sedation During BronchoscopyPhase 4TORSIVNCT01698892
Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy. (TORSIV)
A Phase 4 study testing I.V Sedation and sublingual sedation in people with Sedation During Bronchoscopy, run by Nantes University Hospital at 1 site in France.
Trial summary
Bronchoscopy is a technique which currently allows the investigation of many respiratory diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic procedures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sedation During Bronchoscopy
- What is being tested?
- I.V Sedation and sublingual sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Dec 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged between 18 and 80, who will undergo bronchoscopy
- FEV1≥ 50% of theorical value
- Ambient air saturation at rest ≥ 94%
- No allergy to midazolam, to hydroxyzine, Lidocaine (used for local anesthesia) or one of their compound
- fasting for at least 6 hours
- No indication against bronchoscopy, nor to premedication
- Informed consent signed
Who cannot join
- Pregnant or lactating, women
- PAH patients
- patients undergoing bronchoscopy with bronchoalveolar lavage and / or trans-bronchial biopsy
- Patients with oral anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.
Bronchoscopy is a technique which currently allows the investigation of many respiratory diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic procedures.
Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication before endoscopy, but practices concerning the use of sedation further to the completion of the endoscopy are very heterogeneous.
We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy
- Conditions
- Sedation During Bronchoscopy
- Being tested
- I.V Sedation, sublingual sedation
- Keywords
- I.V. sedation, midazolam, bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I.V SedationDrug
Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation group
sublingual sedationDrug
Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group
| Study group | Role | What they receive |
|---|---|---|
| I.V. sedation | Experimental | Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation Receives: Drug: I.V Sedation |
| sublingual sedation | Active comparator | Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group Receives: Drug: sublingual sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of dyspnea
Intensity of dyspnea assessed by the patient 1h after bronchoscopy in both groups measured by VAS (visual analogue scale) score (in millimeters on a 0 to 100 scale).
Measured: 1 day
Secondary outcomes (7)
VAS Individual scores
VAS Individual scores performed 1 hour after bronchoscopy (cough, nausea, pain, anxiety, overall tolerance)
Measured: 1 day
Blood pressure
Blood pressure (mean blood pressure measurements made before, during and after the exam)
Measured: 1 day
Desaturation frequency
Desaturation frequency during bronchoscopy, defined by the lowering of transcutaneous oxygen saturation below 90%
Measured: 1 day
heart rate
Initial and maximum heart rate during bronchoscopy (continuous monitoring)
Measured: 1 day
OAAS Score
OAAS Score after bronchoscopy
Measured: 1 day
Bronchoscopy duration
Bronchoscopy duration (time difference between the input and output of the examination room, and between the start and end of bronchoscopy)
Measured: 1 day
Comparison of midazolam total dose
Comparison of midazolam total dose administered in each group
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: End study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation During BronchoscopyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698892
- Sponsor's protocol ID
- RC12_0208
- Acronym
- TORSIV
- Status last verified
- Jun 2015
- First submitted
- 1 Oct 2012
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.
- ClinicalTrials.gov ID
- NCT01698892
- Acronym / sponsor ID
- TORSIV / RC12_0208
- Conditions
- Sedation During Bronchoscopy
- Keywords
- I.V. sedation, midazolam, bronchoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End study
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Oct 2012 (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.
Bronchoscopy is a technique which currently allows the investigation of many respiratory diseases (infections, neoplasia, inflammation…) as well as endobronchial therapeutic procedures.
Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication before endoscopy, but practices concerning the use of sedation further to the completion of the endoscopy are very heterogeneous.
We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I.V. sedation | Experimental | Drug: I.V SedationPatients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation |
| sublingual sedation | Active comparator | Drug: sublingual sedationPatients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women aged between 18 and 80, who will undergo bronchoscopy
- FEV1≥ 50% of theorical value
- Ambient air saturation at rest ≥ 94%
- No allergy to midazolam, to hydroxyzine, Lidocaine (used for local anesthesia) or one of their compound
- fasting for at least 6 hours
Key exclusion criteria (4 listed)
- Pregnant or lactating, women
- PAH patients
- patients undergoing bronchoscopy with bronchoalveolar lavage and / or trans-bronchial biopsy
- Patients with oral anticoagulants
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 |
|---|---|---|
| I.V SedationPatients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation group | Drug | I.V. sedation |
| sublingual sedationPatients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group | Drug | sublingual sedation |
Primary outcome
Intensity of dyspnea
Time frame: 1 day
Intensity of dyspnea assessed by the patient 1h after bronchoscopy in both groups measured by VAS (visual analogue scale) score (in millimeters on a 0 to 100 scale).
7 secondary outcomes
VAS Individual scores
Time frame: 1 day
Blood pressure
Time frame: 1 day
Desaturation frequency
Time frame: 1 day
heart rate
Time frame: 1 day
OAAS Score
Time frame: 1 day
Bronchoscopy duration
Time frame: 1 day
Comparison of midazolam total dose
Time frame: 1 day
Results and safety
The study was stopped early (reason given: End study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 I.V Sedation and sublingual sedation in people with Sedation During Bronchoscopy, run by Nantes University Hospital at 1 site in France.
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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Nov 2023. 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 France. 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 was stopped early (reason given: End study). Results are not available in the source record.
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?
Intensity of dyspnea (time frame: 1 day). 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 18 Nov 2023.