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

Phase 4

Terminated

• Conditions: Sedation During Bronchoscopy
• Interventions: Drug: I.V Sedation; Drug: sublingual sedation

• Registration Number: NCT01698892
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I.V. sedation	I.V Sedation	Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation
sublingual sedation	sublingual sedation	Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group

Primary Outcome Measures

Name	Time	Method
Intensity of dyspnea	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).

Secondary Outcome Measures

Name	Time	Method
Blood pressure	1 day	Blood pressure (mean blood pressure measurements made before, during and after the exam)
OAAS Score	1 day	OAAS Score after bronchoscopy
VAS Individual scores	1 day	VAS Individual scores performed 1 hour after bronchoscopy (cough, nausea, pain, anxiety, overall tolerance)
Bronchoscopy duration	1 day	Bronchoscopy duration (time difference between the input and output of the examination room, and between the start and end of bronchoscopy)
Desaturation frequency	1 day	Desaturation frequency during bronchoscopy, defined by the lowering of transcutaneous oxygen saturation below 90%
heart rate	1 day	Initial and maximum heart rate during bronchoscopy (continuous monitoring)
Comparison of midazolam total dose	1 day	Comparison of midazolam total dose administered in each group

Trial Locations

Locations (1)

Cavailles; 🇫🇷 Nantes, France