Intra-ocular Pressure and Ventilation

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.

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Key information

Conditions

Pneumoperitoneum Digestive System Diseases Peritoneal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing elective laparoscopic cholecystectomy

Exclusion criteria

Ophthalmologic and severe Cardiopulmonary diseases

Treatment and study plan

HFJV ventilation

Procedure

The investigators used the Perkins tonometer for monitoring intra-ocular pressure. Evaluation of intra-ocular pressure was done before induction of anesthesia, end of induction, during surgery and at the end of surgery.

IPPV ventilation

Procedure

Primary outcomes

Intra-ocular pressure

Time frame: During procedure

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

The Effects of High Frequency Jet Ventilation on Intra-ocular Pressure During Laparoscopic Operations (Lap. Cholecystectomy) With Positive Pressure Pneumoperitoneum

Acronym: pressure

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Apr 7, 2016
Registry last updated: Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed