Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-24 @ 4:15 AM
Study NCT ID:
NCT02731404
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2016-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-ocular Pressure and Ventilation
Sponsor:
Western Galilee Hospital-Nahariya
Organization:
Study Overview
Official Title:
The Effects of High Frequency Jet Ventilation on Intra-ocular Pressure During Laparoscopic Operations (Lap. Cholecystectomy) With Positive Pressure Pneumoperitoneum
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
pressure
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.
Aim: To study the effects of HFJV on intra-ocular pressure changes (reflecting intra-cranial pressure) during laparoscopic surgery under PP.
Detailed Description:
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: