Finding the Optimal Location for Saturation Measurement During Flexible Bronchoscopy

Completed

• Conditions: Desaturation of Blood; Lung Diseases

• Registration Number: NCT03062137
• Lead Sponsor: Rabin Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Status Verified: 2017-03
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• informed consent

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pulmonary Institute Rabin Medical Center; 🇮🇱 Petach Tikva, Israel