Sedation during examination with bronchoscopy

Phase 1

Conditions: Diagnostic bronchoscopy for referred outpatients
Therapeutic area: Health Care [N] - Health Care Facilities, Manpower, and Services [N02]

Registration Number: EUCTR2015-005274-38-SE

Lead Sponsor: Region Östergötland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

Adult patient (=18 years)
Planned bronchoscopic procedure with sedation in an outpatient setting
The patient have after receiving information about the study given their signed informed consent to participate.
Women of childbearing potential only if use of highly effective contraceptive.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Known pregnancy or planning to be pregnant
Known/suspected allergy or contraindication to any medication within the study.
Functional disability in both hands which affect the possibility to operate the PCS device.
Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Day of bronchoscopy;Main Objective: We hypothesise that the use of propofol patient controlled sedation for outpatient bronchoscopy will be a safe and well accepted procedure by patients and bronchoscopists, and increase the amount of patients ready for discharge after two hours, compared with sedation using midazolam and morphine. ;Secondary Objective: We also hypothesize that patient characteristics affect the amount of propofol self-administered by the patient during patient controlled sedation. ;Primary end point(s): The primary endpoint is the amount of patients ready for discharge within 2 hours, according to the Post Anaesthetic Discharge Scoring System (PADSS) score, after outpatient bronchoscopy.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints; assessment of self-rated patient characteristics using questionaries’ (Sense of Coherence, Coping Strategies Questionnaire, Hospital Anxiety and Depression Scale) and recovery (Post-discharge Surgical Recovery Scale), patients’ satisfaction, bronchoscopist evaluation (perception of cough, bronchial secretion and acceptance of procedure), total dose given of topical anaesthetic, analgesia and sedation drugs.<br><br>Safety variables; level of sedation, vital signs (arterial oxygen saturation, respiratory frequency, non-invasive blood pressure and heart rate) and interventions performed to maintain cardiovascular and respiratory stability. ;Timepoint(s) of evaluation of this end point: Day of bronchoscopy except for recovery which will be evaluated day after bronchoscopy