TOSCA Trial
Research type
Research Study
Full title
A comparison of the effects of Remifentanil PCA and epidural PCEA on transcutaneous carbon dioxide levels in women in labour: A prospective parallel observational pilot study.
IRAS ID
201202
Contact name
Kailash Bhatia
Contact email
Sponsor organisation
Manchester University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This pilot study is intended to provide some preliminary data to understand the transcutaneous carbon dioxide (PtcCO2) trends in labouring women using remifentanil PCA and epidural PCEA (patient controlled analgesia). There have been no recent studies exploring PtcCO2 in these two groups of patients. This is a parallel prospective observational study looking at the change in PtcCO2 levels from baseline (after receiving PCA or PCEA) in these two groups. Of particular interest is to observe if any changes coincide with respiratory depression.
We intend to recruit patients in the induction bay, antenatal assessment unit and delivery suite (not in labour) that are able to consent. When these patients subsequently proceed into labour and receive pain relief of choice, PtcCO2 will be measured using a clip on the ear probe similar to a pulse oximeter probe. The data will be recorded for the duration of the intervention and stored using the TOSCA TM monitor. The monitor will be silenced and covered so that it does not influence or interfere with clinical management. There will be no deviation from the standard trust protocol in the management of these patients. The data will be retrieved electronically post delivery and PtcCO2 trend will be analysed.
The numbers we would need to achieve statistical significance at p<0.05 are 20 patients in each group. We are hoping to detect a change in PtcCO2 trends during any encountered episodes of respiratory depression. This study would hopefully provide data to plan a larger observational study of PtcCO2 trends in parturients using remifentanil PCA and epidural PCEA. Relating PtcCO2 with physiological parameters and clinical interventions could provide useful information to better understand apnoea/hypopnoea associated with opiate analgesia administration in this patient population.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
18/WM/0072
Date of REC Opinion
15 Mar 2018
REC opinion
Favourable Opinion