Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy. (TORSIV)

Study Overview
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Brief Summary
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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

Official Title
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Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.

Conditions
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Sedation During Bronchoscopy

Intervention / Treatment
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* Drug: I.V Sedation
* Drug: sublingual sedation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnant or lactating, women PAH patients patients undergoing bronchoscopy with bronchoalveolar lavage and / or trans-bronchial biopsy Patients with oral anticoagulants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I.V. sedation<br>Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation | Drug: I.V Sedation<br>* Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation group<br>|
| Active Comparator: sublingual sedation<br>Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group | Drug: sublingual sedation<br>* Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Individual scores | VAS Individual scores performed 1 hour after bronchoscopy (cough, nausea, pain, anxiety, overall tolerance) | 1 day | 
| Blood pressure | Blood pressure (mean blood pressure measurements made before, during and after the exam) | 1 day | 
| Desaturation frequency | Desaturation frequency during bronchoscopy, defined by the lowering of transcutaneous oxygen saturation below 90% | 1 day | 
| heart rate | Initial and maximum heart rate during bronchoscopy (continuous monitoring) | 1 day | 
| OAAS Score | OAAS Score after bronchoscopy | 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) | 1 day | 
| Comparison of midazolam total dose | Comparison of midazolam total dose administered in each group | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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I.V. sedation, midazolam, bronchoscopy