NCT03062137

Brief Summary

An observational comparison of different locations of saturation measurements during Flexible Bronchoscopy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2017

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

January 31, 2017

Last Update Submit

March 30, 2017

Conditions

Lung DiseasesDesaturation of Blood

Keywords

bronchoscopysaturation

Outcome Measures

Primary Outcomes (2)

  • Value changes between locations

    Difference of 10% of blood saturation between different locations during sedation for bronchoscopy procedure.

    Through completion of bronchoscopy procedure an average of 30 minutes

  • Time changes between locations

    The level of desaturation of 90% is checked in the different monitors and the gap in seconds is registered

    Through completion of bronchoscopy procedure an average of 30 minutes

Secondary Outcomes (1)

  • gap between arterial gas sample and different monitors

    Through completion of bronchoscopy procedure an average of 30 minutes

Interventions

blood gas samplingDIAGNOSTIC_TEST

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

100 patients, adults, undergoing Flexible Fiberoptic Bronchoscopy under sedation

You may qualify if:

  • informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Institute Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Mordechai R Kramer, MD

    Rabin Medical Center, Belinson Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pulmonary Institute

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 23, 2017

Study Start

January 1, 2017

Primary Completion

March 30, 2017

Study Completion

March 30, 2017

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)