Condition category
Respiratory
Date applied
03/02/2011
Date assigned
03/05/2011
Last edited
27/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Daiana Stolz

ORCID ID

Contact details

Clinic of Pneumology and Respiratory Cell Research
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Bolus administration versus continuous infusion of Propofol sedation in flexible bronchoscopy: a randomised non-inferiority trial

Acronym

Propofol Study

Study hypothesis

Propofol is a sedative-hypnotic with a rapid onset of action coupled with smooth and rapid recovery. Multiple studies using it as a sedative agent for gastrointestinal endoscopic procedures have shown propofol to be safe and effective. More recently propofol-only sedation was shown to be a feasible and safe sedation method for bronchoscopic procedures as well. In the vast majority of studies an intermittent bolus technique was used. Hardly any data exists for the use of propofol using a continuous infusion as the sedation method in bronchoscopy. To show that for sedation in flexible bronchoscopy the use of propofol using a continuous infusion is associated with a incidence of complications within 5% of that of an intermittent bolus technique, or better.

Ethics approval

The study protocol has been submitted to the Ethics Committee, Basel, Switzerland

Study design

Prospective randomised non-inferiority single-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pulmonary disease diagnosis, need for flexible bronchoscopy

Intervention

Propofol continous infusion versus bolus for sedation in flexible bronchoscopy

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Number (percentage) of complications (oxygen desaturation less than or equal to 90%
2. Need for chin-support
3. Need for nasopharyngeal or oropharyngeal airway insertion
4. Need for intubation
5. Hypotension with a systolic blood pressure of less than 90 mmHg
6. Minor or major bleeding
7. Intensive Care Unit [ICU] need post-bronchoscopy
8. Pneumothorax
9. Need to abort bronchoscopy
10. Death
These outcomes are assessed by the study physician during and up to 24 hours after the procedure

Secondary outcome measures

1. Total dose of propofol,dose of propofol per kilogram body weight and per minute
2. Duration of the procedure
3. Mean lowest oxygen saturation during the procedure
4. Mean lowest systolic blood pressure during the procedure
5. Hemodynamic parameters other than blood pressure during and after the procedure
6. Cough scores, as assessed by a Visual Analogue Scale (VAS) by patients, nurses and physicians during and 2 hours after the procedure
7. Patient discomfort
8. Median patient overall well-being (comfort) at 1 and 2 hours after the procedure
9. Willingness to undergo a repeated procedure, assessed by a VAS 2 hours after the procedure
10. Fear of undergoing a repeated procedure, assessed by a VAS 2 hours after the procedure
11. Supplemental lidocaine doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchoscopist
12. Medication doses, assessed by the nurse team and study physician during the procedure, as judged by the bronchoscopist

Overall trial start date

01/04/2011

Overall trial end date

30/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18 or older
2. Patients undergoing flexible bronchoscopy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

702

Participant exclusion criteria

1. Known allergy to propofol
2. Mental disorder preventing appropriate judgment concerning study participation
3. Pregnancy and breast-feeding
4. Intubated patients

Recruitment start date

01/04/2011

Recruitment end date

30/09/2012

Locations

Countries of recruitment

Switzerland

Trial participating centre

Clinic of Pneumology and Respiratory Cell Research
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

c/o Prof. Michael Tamm
Clinic of Pneumology and Respiratory Cell Research
University Hospital Basel
Petersgraben 4
4031 Basel
4031
Switzerland

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Hospital Basel (Switzerland) - Clinic of Pneumology and Respiratory Cell Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23900984

Publication citations

  1. Results

    Grendelmeier P, Tamm M, Pflimlin E, Stolz D, Propofol sedation for flexible bronchoscopy: a randomised, noninferiority trial., Eur. Respir. J., 2014, 43, 2, 591-601, doi: 10.1183/09031936.00200412.

Additional files

Editorial Notes