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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01698892
First received: October 1, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Sedation During Bronchoscopy
Drug: I.V Sedation
Drug: sublingual sedation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Intensity of dyspnea [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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:
  • VAS Individual scores [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    VAS Individual scores performed 1 hour after bronchoscopy (cough, nausea, pain, anxiety, overall tolerance)

  • Blood pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Blood pressure (mean blood pressure measurements made before, during and after the exam)

  • Desaturation frequency [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Desaturation frequency during bronchoscopy, defined by the lowering of transcutaneous oxygen saturation below 90%

  • heart rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Initial and maximum heart rate during bronchoscopy (continuous monitoring)

  • OAAS Score [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    OAAS Score after bronchoscopy

  • Bronchoscopy duration [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Bronchoscopy duration (time difference between the input and output of the examination room, and between the start and end of bronchoscopy)

  • Comparison of midazolam total dose [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Comparison of midazolam total dose administered in each group


Estimated Enrollment: 84
Study Start Date: October 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698892

Locations
France
Cavailles Recruiting
Nantes, France, 44000
Contact: ARNAUD CAVAILLES, PH    02.40.16.52.38    arnaud.cavailles@chu-nantes.fr   
Principal Investigator: ARNAUD CAVAILLES, PH         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01698892     History of Changes
Other Study ID Numbers: 12_0208
Study First Received: October 1, 2012
Last Updated: February 19, 2014
Health Authority: France : ANSM

Keywords provided by Nantes University Hospital:
I.V. sedation, midazolam, bronchoscopy

ClinicalTrials.gov processed this record on September 18, 2014