Finding the Optimal Location for Saturation Measurement During Flexible Bronchoscopy

March 30, 2017 updated by: Mordechai Kremer, Rabin Medical Center

Optimal Location of Saturation Measurement During Flexible Fiberoptic Bronchoscopy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study group will include 100 patients undergoing flexible fiberoptic bronchoscopy (FFB).

The patients will receive sedation with Midazolam, Fentanyl and Propofol. All patients will receive supplemental oxygen via nasal cannula (2-4 L/min) before the beginning of the procedure.

In all cases, patients will be monitored using continuous electrocardiography, pulse oximetry (on patients finger), and transcutaneous carbon dioxide and saturation (on patients earlobe), and automated noninvasive blood pressure recordings every 5 minutes. All parameters will be recorded from accepting patient to bed of procedure until 10 minutes after removal of FFB from nasopharynx.

The saturation will be measured in 3 different locations (one pulse is added in other earlobe). additionally, A blood gas sample will be taken during discrepancy between different measurements.

Immediately after the end of procedure, the measurements from 3 different monitors will be printed, and the blood sample be taken to a gas sample machine by the investigator.

Desaturation value and time will be compared between the different locations. The blood arterial saturation will be compared to other measurements taken at the same time.

Study Type

Observational

Enrollment (Actual)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach Tikva, Israel, 49100
        • Pulmonary Institute Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

100 patients, adults, undergoing Flexible Fiberoptic Bronchoscopy under sedation

Description

Inclusion Criteria:

  • informed consent

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Value changes between locations
Time Frame: Through completion of bronchoscopy procedure an average of 30 minutes
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
Time Frame: Through completion of bronchoscopy procedure an average of 30 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
gap between arterial gas sample and different monitors
Time Frame: Through completion of bronchoscopy procedure an average of 30 minutes
during differences of more than 5% between finger and earlobe monitors we will take an arterial blood sample and the lab result will be compared to the measurements at the same time
Through completion of bronchoscopy procedure an average of 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Mordechai R Kramer, MD, Rabin Medical Center, Belinson Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 30, 2017

Study Completion (Actual)

March 30, 2017

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC17001ctl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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