Intra-ocular Pressure and Ventilation

NCT ID: NCT02731404

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-01-31

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 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).

Conditions

Pneumoperitoneum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

IPPV ventilation

standard intermittent positive pressure ventilation in patients undergoing laparoscopic cholecystectomy

Group Type: OTHER

IPPV ventilation

Intervention Type: 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.

HFJV ventilation

high frequency jet ventilation in patients undergoing laparoscopic cholecystectomy

Group Type: OTHER

HFJV ventilation

Intervention Type: 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.

Interventions

HFJV ventilation

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.

Intervention Type: PROCEDURE

IPPV ventilation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing elective laparoscopic cholecystectomy

Exclusion Criteria

• Ophthalmologic and severe Cardiopulmonary diseases

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Amitai Bickel MD

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amitai Bickel, MD

Role: PRINCIPAL_INVESTIGATOR

Western Galilee Hospital, Bar Ilan Faculty of Medicine

Other Identifiers

NHR-12-0094

Identifier Type: -

Identifier Source: org_study_id