Document Number: SOP/11/V3
Title: Measurement of SpirometryAuthor: Liz Waxman/Richard Leece Version 3
Date reviewed:
/21/06/2013
Effective from:
/14/10/13
Valid to:
/13/10/16
Superseded version number and date (if applicable):
/Version 2 16/06/10
1.0 Purpose
This Standard Operating Procedure (SOP) describes the correct procedure for the measurement of Spirometry during clinical research studies.
2.0 Scope
This SOP applies to the correct procedure to be followed when obtaining Spirometry measurements.
3.0 Responsibilities
Only staff trained in Spirometry should perform this procedure as per section 2.8 of ICH GCP guidelines.
4.0 Procedures
4.1 The machine will be calibrated as per the manufacturer’s
instructions.
4.2 The participant will be taken into a private room with their parent or legal representative where the spirometry will take place.
4.3 The participant’s height and weight will be measured (see SOP/03/V1 and SOP/04/V1).
4.4 The procedure will be explained to the participant and consent obtained. It should be made clear what the process will be measuring, for example, how much air their lungs can hold and how quickly they are able to breathe out.
4.5 The participant will be asked to stand up straight and tall.
4.6 They will be asked to take a deep breath in and fill their lungs as much as they can.
4.7 They will then be asked to make a tight seal around the mouth-piece of the spirometer and breath out as hard, as fast and as long as possible, until they feel their lungs have emptied. No nose clip will be used. A bacterial filter is required for best practice.
4.8 The operator will give encouragement and an incentive may appear on the screen to help the participant do their best.
4.9 The participant will be asked to this 3-5 times and the result showing the greatest sum of FEV1 and FVC will be recorded in the CRF. The flow-volume curve should have a smooth rise and descent. The VBE will also be calculated and used.
4.10 The recording of the results in the CRF should be accurate and follow section 2.10 of the ICH GCP guidelines.
4.11 If post bronchodilator response is to be recorded salbutamol 200micrograms will then be administered to the participant. After 15mins steps 4.1 to 4.9 will be repeated and the best FEV1 result will be recorded in the CRF
4.12 The participant will be thanked for their involvement.
5.0 Related Documents
· Case Report Form
· Study protocol
· SOP/03/V1 – Measurement and Recording of Height
· SOP/04/V1 – Measurement and Recording of Weight
6.0 References
· ICH/GCP Directive/guidelines
· EU Clinical Trials Directive
· Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, et al. Standardisation of Spirometry. European Respiratory Journal 2005; 26:319 - 338.
Approval:Name: Prof S Greene Position: Network Director
Signature: Date: 14/10/2013
Page 2 of 2
Document number: SOP/11/V3 Effective from: 14/10/13 Version 3
Valid to: 13/10/16