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Intra-ocular Pressure and Ventilation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02731404
Acronym
pressure
Enrollment
26
Registered
2016-04-07
Start date
2015-01-31
Completion date
2016-01-31
Last updated
2016-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumoperitoneum

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).

Interventions

PROCEDUREHFJV 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.

PROCEDUREIPPV 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.

Sponsors

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients undergoing elective laparoscopic cholecystectomy

Exclusion criteria

* Ophthalmologic and severe Cardiopulmonary diseases

Design outcomes

Primary

MeasureTime frame
Intra-ocular pressureDuring procedure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026