Effect of Warm Humidified Insufflation on Lens Fogging during Laparoscopic Cholecystectomy. A Single centre, superiority, blinded randomised controlled trial.

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This study is a medical device study on the effect of warm humidified carbon dioxide on optical clarity in laparoscopic cholecystectomy surgery. The medical device being used is called HumiGard and is approved for use in humans and is in routine medical use in several countries. It is manufactured by Fisher and Paykel Healthcare Ltd. Fisher and Paykel Healthcare (referred to as ‘FPH’) is a New Zealand owned medical device company and is the sponsor of this trial. Loss of optical clarity during laparoscopic surgery remains a major concern for surgeons. Clear vision in surgery is important not only for safety by preventing accidental injury, but also to improve precision and reduce operative time. The condensation that leads to “fogging” occurs when the temperature of the camera lens is at or below the temperature of the air surrounding the object and this study aims at investigating whether a new surgical humidifier can reduce lens fogging by warming and humidifying the carbon dioxide gas used during laparoscopic cholecystectomies. Participants undergoing laparoscopic cholecystectomy surgery at Auckland Hospital or Greenlane Hospital who meet the inclusion and exclusion criteria will be offered the opportunity to participate in the pilot study. To measure the number of fogging events that occur during a routine procedure, the video feed of the laparoscopic camera will be recorded and analysed post-operatively. This camera and its recordings are nearly entirely internal and so there will be no way to identity participants from the video. In addition to the laparoscopic camera, a camera will be placed directly about the external surgical area as to capture all events that occur outside of the abdomen (not recorded by the laparoscopic camera). During surgery, investigators or a research nurse will also take record of other measurements that will be monitored as part of standard of care. The measurements will include data such as core body temperature and the length of the procedure. Video/image analysis of laparoscopic camera will be done at a later time point by medical professionals.

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