Effect of Prone Positioning on Intra-ocular Pressure in Patients With Acute Respiratory Distress Syndrome (ARDS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- To study percentage change in intra-ocular pressure due to prone positioning in patients with ARDS.
Study Overview
Brief Summary
Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in intensive care units (ICU). This syndrome is associated with high morbidity and mortality. In management of ARDS patients, lung protective ventilation and prone ventilation are key strategies which have shown survival benefits in recent years and now become standard part of care in these patient. Prone positioning used for surgeries in operation room has been reported with ocular complications, of which vision loss is one of the devastating complications. There is scarcity of literature on effect of prone positioning on intra-ocular pressure (IOP) in critically ill patients. The purpose of our study is to evaluate the effect of prone position on IOP in critically ill patients and follow up for other ocular complication among survivors.
Detailed Description
Introduction and rationale of the study:
Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in intensive care units (ICU). This syndrome is associated with high morbidity and mortality. In management of ARDS patients, lung protective ventilation and prone ventilation are key strategies which have shown survival benefits in recent years and now become standard part of care in these patient.
Prone positioning used for surgeries in operation room has been reported with ocular complications, of which vision loss is one of the devastating complications. Multiple risk factors are reported but orbital compression during prone positioning, excess intravenous fluids, hypotension and duration of prone positioning were the predominant factors. Perioperatively patients, who underwent prone positioning for surgeries can be followed up for symptoms of any complications after the surgery, but this follow up for symptoms is difficult in intensive care units as most of the patients after prone ventilation, will not be able to communicate. The hours of prone ventilation are nearly 3-4 times more, when compared intra-operatively which can definitely increase intra-ocular pressure(IOP) significantly. Most of the patients will be hemodynamically unstable on vasopressor supports, unlike intra-operatively, which can significantly affect ocular perfusion pressure (mean arterial pressure - intra-ocular pressure), making ICU patients with definitely high risk for ocular complication. The purpose of our study is to evaluate the effect of prone position on IOP in critically ill patients and follow up for other ocular complication among survivors.
Tonometry guided IOP measurement is one of the commonly used modality to assess IOP. It has been used in assessing IOP in prone position in awake volunteers with documented increase in IOP within few hours of prone positioning on operating tables It has been studied under anesthesia with elevated IOP and significantly increased IOP in the dependent eye.
Primary objective:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (age >18 years) patients with ARDS requiring prone ventilation
Exclusion Criteria
- •Patient with age <18 years
- •Clinical conditions with suspected raised intra-cranial pressure (ICP)
- •Previous eye trauma or disease or surgery
- •Patients with family history of glaucoma or history of pain and redness of eye (obtained from patient's family)
- •Any prone positioning of less than 6 hours duration (planned or unplanned)
Outcomes
Primary Outcomes
To study percentage change in intra-ocular pressure due to prone positioning in patients with ARDS.
Time Frame: Baseline (pre-prone) and after termination of prone position (post-prone) at 5, 10, 15 and 30 minutes.
The investigators will study percentage change in intra-ocular pressure due to prone positioning in patients with ARDS.
Secondary Outcomes
- Ophthalmic examination for anterior segment and posterior segment of both eyes will be done in survivors.(Before discharge from intensive care unit, and after that at 1 month and at 3 months, in follow up.)