NCT02246023

Brief Summary

After randomization, the subjects undergo flexible bronchoscopy either with fractionated propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate, oxygen saturation, and oxygen requirement are measured continuously during the procedure and thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted continuously during and after the procedure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4 lung-cancer

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 14, 2016

Status Verified

June 1, 2015

Enrollment Period

11 months

First QC Date

September 15, 2014

Last Update Submit

April 13, 2016

Conditions

Lung CancerSarcoidosisInterstitial Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Mean arterial oxygen saturation

    From induction of sedation until recovery (eye opening/answer to verbal stimuli), in average 45 minutes

    During bronchoscopy

Secondary Outcomes (6)

  • Number of occasions with recorded an oxygen saturation of < 90%

    During bronchoscopy

  • Number of an oxygen desaturation of > 4% from baseline

    During bronchoscopy

  • Number of occasions with a systolic blood pressure < 90 mmHg during bronchoscopy, maximum oxygen requirement,

    During bronchoscopy

  • Frequency of dose adjustments

    During bronchoscopy

  • Cumulative propofol dose

    At end of bronchoscopy

  • +1 more secondary outcomes

Study Arms (2)

Fractionated propofol administration

ACTIVE COMPARATOR

Flexible bronchoscopy in moderate sedation with fractionated propofol administrations: Patients receive an initial 20 mg of propofol, followed by a carefully titrated dose of10-20 mg propofol based on the clinical response. Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy

Device: Flexible bronchoscopy in moderate sedationDevice: Oxygen saturationDevice: Blood pressureDevice: Propofol dosageDevice: Recovery time after bronchoscopy

Propofol-TCI

EXPERIMENTAL

Flexible bronchoscopy in moderate sedation with TCI propofol perfusor: Flexible bronchoscopy is started after reaching the initial targeted effect-site concentration (Ce) of 2.5 μg/mL using the Schnider pharmacokinetic model described elsewhere. Thereafter, Ce is adjusted by increments of 0.2 μg/mL depending on the clinical effect, in order to maintain the required level of sedation. Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy The propofol-TCI perfusor is an active infusion system for fluid management. In the study, the Perfusor® Space of B. Braun AG, Melsungen is used exclusively.

Device: Flexible bronchoscopy in moderate sedationDevice: Oxygen saturationDevice: Blood pressureDevice: Propofol dosageDevice: Recovery time after bronchoscopy

Interventions

Flexible bronchoscopy in moderate sedationDEVICE

Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;

Fractionated propofol administrationPropofol-TCI
Oxygen saturationDEVICE

Continuous measurement of oxygen saturation;

Fractionated propofol administrationPropofol-TCI
Blood pressureDEVICE

Measurement of non-invasive blood pressure every 3 minutes

Fractionated propofol administrationPropofol-TCI
Propofol dosageDEVICE

Report of dose adjustments und cumulative propofol dosage;

Fractionated propofol administrationPropofol-TCI
Recovery time after bronchoscopyDEVICE

Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)

Fractionated propofol administrationPropofol-TCI

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects undergoing a planned, ambulatory flexible bronchoscopy (for transbronchial lung biopsy or endobronchial ultrasound guided procedures) in moderate sedation, aged between 18 and 85 years

You may not qualify if:

  • History of solid organ or bone marrow transplantation with the use of an immunosuppressive therapy
  • HIV infection on anti-retroviral therapy
  • Alcohol consumption more than two standard drinks per day
  • Use of illicit drugs (heroin, opiates)
  • Any contraindication to use propofol for sedation (e.g. allergy)
  • Body mass index \> 35 kg/m2
  • Mental disorder preventing appropriate judgment concerning study participation
  • Missing written patient's informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Lung NeoplasmsSarcoidosisLung Diseases, Interstitial

Interventions

Conscious SedationBlood Pressure

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaVital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Daniel Franzen, MD

    Division of Pulmonology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Daniel Franzen

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 22, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

April 14, 2016

Record last verified: 2015-06

Locations

CH(1)