Finding the Optimal Location for Saturation Measurement During Flexible Bronchoscopy

Sponsor
Rabin Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03062137
Collaborator
(none)
116
1
2.9
40.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: blood gas sampling

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 Design

Study Type:
Observational
Actual Enrollment :
116 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Optimal Location of Saturation Measurement During Flexible Fiberoptic Bronchoscopy
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Mar 30, 2017
Actual Study Completion Date :
Mar 30, 2017

Outcome Measures

Primary Outcome Measures

  1. Value changes between locations [Through completion of bronchoscopy procedure an average of 30 minutes]

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

  2. Time changes between locations [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

Secondary Outcome Measures

  1. gap between arterial gas sample and different monitors [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • informed consent
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pulmonary Institute Rabin Medical Center Petach Tikva Israel 49100

Sponsors and Collaborators

  • Rabin Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mordechai Kremer, Head of Pulmonary Institute, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT03062137
Other Study ID Numbers:
  • RMC17001ctl
First Posted:
Feb 23, 2017
Last Update Posted:
Mar 31, 2017
Last Verified:
Mar 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Mordechai Kremer, Head of Pulmonary Institute, Rabin Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2017