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

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

Study Overview

• Status: Terminated
• Conditions: Sedation During Bronchoscopy
• Intervention / Treatment: Drug: I.V Sedation; Drug: sublingual sedation

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Cavailles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimated): October 3, 2012

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: I.V. sedation, midazolam, bronchoscopy
• Other Study ID Numbers: RC12_0208