Clinical Trial: Intra-ocular Pressure and Ventilation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effects of High Frequency Jet Ventilation on Intra-ocular Pressure During Laparoscopic Operations (Lap. Cholecystectomy) With Positive Pressure Pneumoperitoneum
Brief Summary:
Background: Positive pressure pneumoperitoneum (PP) may involve adverse pathophysiological changes, including increased intra-thoracic and ocular pressure, when combined with standard ventilation. High frequency jet ventilation (HFJV) was reported to reduce the adverse cardiovascular effects during laparoscopic cholecystectomy.
Aim: To study the effects of HFJV on intra-ocular pressure changes (reflecting intra-cranial pressure) during laparoscopic surgery under PP.
Detailed Summary:
Patients and methods: The investigators studied 2 groups of patients electively scheduled for laparoscopic cholecystectomy. The study group included 10 patients that were ventilated by high frequency jet ventilation (HFJV). In the control group (16 patients) the investigators used the standard intermittent positive pressure ventilation (IPPV). Both groups were matched according to clinical and hemodynamic parameters. Intra-ocular pressure was measured by a senior ophthalmologist that was blinded to the ventilation technique. Laparoscopic surgery was done as usual, and the intra-peritoneal pressure was automatically set on 14 mmHg. Statistical significance was considered whenever P value was less than 0.05.
The investigators anticipate that the use of HFJV during laparoscopic operations under PP may prevent increased intra-ocular pressure that accompanies increased intra-abdominal pressure under conventional ventilation (IPPV).
Sponsor: Western Galilee Hospital-Nahariya
Current Primary Outcome: Intra-ocular pressure [ Time Frame: During procedure ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Western Galilee Hospital-Nahariya
Dates:
Date Received: March 22, 2016
Date Started: January 2015
Date Completion:
Last Updated: April 6, 2016
Last Verified: April 2016
