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Intra-ocular Pressure and Ventilation (pressure)

W

Western Galilee Hospital-Nahariya

Status

Completed

Conditions

Pneumoperitoneum

Treatments

Procedure: IPPV ventilation
Procedure: HFJV ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT02731404
NHR-12-0094

Details and patient eligibility

About

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.

Full 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).

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients undergoing elective laparoscopic cholecystectomy

Exclusion criteria

  • Ophthalmologic and severe Cardiopulmonary diseases

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

26 participants in 2 patient groups

IPPV ventilation
Other group
Description:
standard intermittent positive pressure ventilation in patients undergoing laparoscopic cholecystectomy
Treatment:
Procedure: IPPV ventilation
HFJV ventilation
Other group
Description:
high frequency jet ventilation in patients undergoing laparoscopic cholecystectomy
Treatment:
Procedure: HFJV ventilation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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