CO-PILOT

• Research type

  Research Study

• Full title

  The Assessment of Heated and Humidified Carbon Dioxide Insufflation in Laparoscopic Procedures - A Pilot Study

• IRAS ID

  260794

• Contact name

  Anil Reddy

• Contact email

  anil.reddy@nhs.net

• Sponsor organisation

  South Tees Hospitals NHS Foundation Trust

• Duration of Study in the UK

  0 years, 3 months, 1 days

• Research summary

  Study Title

  CO-PILOT: The Assessment of Heated and Humidified Carbon Dioxide Insufflation in Laparoscopic Procedures - A Pilot Study

  Short Title - CO-PILOT

  Study Design
  Pilot Study. Double-blinded Randomised Controlled Trial

  Study Participants
  Elective general, colorectal, gynaecological and urological surgical patients at James Cook University Hospital.

  Planned Size of Sample - 100 patients

  Follow up duration
  From post-operative transfer to ward to discharge from hospital.

  Planned Study Period
  Two-months data collection. One month data collation and analysis.

  Primary Objective:
  To determine if the use of humidified carbon dioxide insufflation, in either elective or emergency laparoscopic procedures, reduces the amount of post-operative pain relief required in comparison to the current standard of un-humidified carbon dioxide.

  Secondary Objectives:
  To determine the effect of humidified carbon dioxide insufflation in laparoscopy on secondary outcomes such as patient observations (i.e. heart rate, respiratory rate, core body temperature), post-operative fluid requirement, quality of life scores and overall pain scoring tools.

  To determine if the routine use of humidified carbon dioxide, during either elective or emergency laparoscopic procedures, is cost-effective in comparison to the current insufflation practices in place.

• REC name

  North East - York Research Ethics Committee

• REC reference

  19/NE/0252

• Date of REC Opinion

  8 Aug 2019

• REC opinion

  Favourable Opinion