Finding the Optimal Location for Saturation Measurement During Flexible Bronchoscopy

Lung Diseases Clinical Trial

Official title:

Optimal Location of Saturation Measurement During Flexible Fiberoptic Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03062137
• Other study ID #: RMC17001ctl
• Status: Completed
• Phase: N/A
• First received: January 31, 2017
• Last updated: March 30, 2017
• Start date: January 1, 2017
• Est. completion date: March 30, 2017

Study information

• Verified date: March 2017
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• informed consent

Exclusion Criteria:

Related Conditions & MeSH terms

• Desaturation of Blood
• Lung Diseases

Intervention

Diagnostic Test:
• blood gas sampling

Locations

Country	Name	City	State
Israel	Pulmonary Institute Rabin Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	gap between arterial gas sample and different monitors	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