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Intra-ocular Pressure and Ventilation (pressure)

Primary Purpose

Pneumoperitoneum

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HFJV ventilation
IPPV ventilation
Sponsored by
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumoperitoneum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

  • Ophthalmologic and severe Cardiopulmonary diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    IPPV ventilation

    HFJV ventilation

    Arm Description

    standard intermittent positive pressure ventilation in patients undergoing laparoscopic cholecystectomy

    high frequency jet ventilation in patients undergoing laparoscopic cholecystectomy

    Outcomes

    Primary Outcome Measures

    Intra-ocular pressure

    Secondary Outcome Measures

    Full Information

    First Posted
    March 22, 2016
    Last Updated
    April 6, 2016
    Sponsor
    Western Galilee Hospital-Nahariya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02731404
    Brief Title
    Intra-ocular Pressure and Ventilation
    Acronym
    pressure
    Official Title
    The Effects of High Frequency Jet Ventilation on Intra-ocular Pressure During Laparoscopic Operations (Lap. Cholecystectomy) With Positive Pressure Pneumoperitoneum
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Western Galilee Hospital-Nahariya

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumoperitoneum

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    26 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IPPV ventilation
    Arm Type
    Other
    Arm Description
    standard intermittent positive pressure ventilation in patients undergoing laparoscopic cholecystectomy
    Arm Title
    HFJV ventilation
    Arm Type
    Other
    Arm Description
    high frequency jet ventilation in patients undergoing laparoscopic cholecystectomy
    Intervention Type
    Procedure
    Intervention Name(s)
    HFJV ventilation
    Intervention Description
    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
    Intervention Name(s)
    IPPV ventilation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Intra-ocular pressure
    Time Frame
    During procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing elective laparoscopic cholecystectomy Exclusion Criteria: Ophthalmologic and severe Cardiopulmonary diseases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amitai Bickel, MD
    Organizational Affiliation
    Western Galilee Hospital, Bar Ilan Faculty of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Intra-ocular Pressure and Ventilation

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