Document Number: SOP

Document Number: SOP/10/V3

Date reviewed:

21/01/14

Reviewed by:

Lindsay Vallance

Effective from:

21/05/13

Valid to:

20/05/16

Superseded version number and date (if applicable):

Version 2 03/09/10

1.0Purpose

This Standard Operating Procedure (SOP) describes the correct procedure

for obtaining Exhaled Nitric Oxide Measurements during research studies.

2.0Scope

This SOP applies to the correct procedure to be followed when obtaining Exhaled Nitric Oxide Measurements.

3.0Responsibilities

Only staff trained in the measurement of Exhaled Nitric Oxide should perform this procedure as per section 2.8 of ICH GCP guidelines.

4.0Procedures

4.1The participant’s details are entered into the computer.

4.2 An expiratory time of 6 seconds will be used and the instant flow

will be disabled (or in accordance with the study protocol).

4.3 An incentive device will be used to encourage the

participant to exhale for the required length of time.

4.4The participant’s parent or guardian will be present throughout the

procedure.

4.5The process of breath analysis will be explained to the participant and their parent or guardian and consent obtained. A nose clip is not required.

4.6 A clean mouth-piece with filter will be attached to the tubing and the participant will be asked to stand up.

4.7The participant will be asked to breathe out then put the hand-held mouth-piece in their mouth and make a tight seal with their lips.

4.8They will then be asked to breathe in or “suck” through the mouth-piece. By doing this they will be inhaling nitric oxide free air.

4.9The participant is asked to breathe out which prompts the incentive to appear on the screen. This is intended to keep the participant exhaling at the correct flow and at the correct flow-rate. The operator will also encourage the participant to do this.

4.10The participant will be asked to repeat the procedure until 2

readings are obtained within 5% of each other, or 3 readings are

obtained within 10% of each other (or in accordance with the

study protocol).

4.11Record the results in the CRF. These should be accurate and

follow section 2.10 of the ICH GCP guidelines.

4.12The participant is thanked for their involvement.

4.13A clean mouth-piece with filter will be applied to the tubing and

will remain in place while the machine is not in use to prevent air-borne particulate matter entering into the analyser.

4.14The analyser will be put on stand-by.

4.15Calibration of the analyser will be carried out as per the

manufacturer’s instructions.

5.0Related Documents

• Study protocol
• Case report Form

6.0References

• ICH/GCP Directive/guidelines
• EU Clinical Trials Directive
• American Thoracic Society, Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide; American Journal of Respiratory Critical Care Medicine 2005;171:912-930.

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Document number: SOP/10/V3Effective from:21/05/13Version3

Valid to: 20/05/16