CO2 monitoring and respiratory polygraphy in CF - pilot

• Research type

  Research Study

• Full title

  A pilot study to assess the role of transcutaneous CO2 monitoring in combination with respiratory polygraphy in patients with cystic fibrosis\n

• IRAS ID

  265360

• Contact name

  Giulia Spoletini

• Contact email

  giulia.spoletini@nhs.net

• Sponsor organisation

  Leeds Teaching Hospital NHS Trust

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Research Summary
  Cystic fibrosis (CF) is a life-limiting genetic condition characterised by involvement of several organs across the body. Most complications and death are generally the result of lung involvement, which causes progressive respiratory failure with low oxygen levels and raised carbon dioxide (waste gas).\n\nRoutinely, individuals with CF are monitored with lung function testing, and oxygen assessment consisting of measuring oxygen levels during night and exercise with a finger probe and taking a blood sample (from an artery in the wrist or an earlobe) to directly check oxygen and carbon dioxide levels. \n\nPrevious research showed that patients with CF, including children, with mild lung disease present changes in respiratory pattern during sleep in the form of nocturnal hypoventilation or sleep disordered breathing, neither of which can be diagnosed with simple overnight oximetry. \n\nPreliminary data from our Unit revealed that patients with CF tend to have high level of serum bicarbonate, which tend to reach an apex close to death. We hypothesise that raised bicarbonate is a consequence of nocturnal hypoventilation or disturbed breathing during sleep. \n\nIn this pilot study we want to assess if the results of transcutaneous monitoring of CO2 correlate with level of serum bicarbonate. We also want to rule out that increased CO2 overnight is associated with sleep disordered breathing. In addition, we want to assess if patients with different baseline characteristics (lung function and blood results) have different results overnight. These preliminary results could lead to the development of larger trials focusing on the use of CO2 monitoring and respiratory polygraphy in patients with CF to identify anomalies in respiratory function and gas exchanges earlier on in the progression of disease, when only indirect signs of respiratory failure might be present (i.e. raised bicarbonate). \n

  Summary of Results
  The study received all approvals and was given the green light to start shortly before the first wave of the COVID-19 pandemic. Before the pandemic, and the associated limitations and guidance for research, no participants were enrolled. The study was then put on hold during the pandemic (according to recommendations).

  In the meanwhile a life-changing medication has been approved for the majority of people with CF. The routine use in clnical practice of this medication has changed the outlook for people with CF, and has also affected the underlying rationale for the study, making it outdated. As such, the research team has withdrawn the study.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  19/YH/0305

• Date of REC Opinion

  6 Nov 2019

• REC opinion

  Further Information Favourable Opinion