Effect of Prone Positioning on Intra-ocular Pressure in ARDS Patients

NCT02711930 | Completed

• 1 other identifier: 2016-55-DM-EXP
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

intra-ocular pressure; prone ventilation

Outcome Measures

Primary Outcomes (1)

• To study percentage change in intra-ocular pressure due to prone positioning in patients with ARDS.

  The investigators will study percentage change in intra-ocular pressure due to prone positioning in patients with ARDS.

  Baseline (pre-prone) and after termination of prone position (post-prone) at 5, 10, 15 and 30 minutes.

Secondary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients having acute respiratory distress syndrome and requiring prone ventilation during ICU stay.

You may qualify if:

• Adult (age \>18 years) patients with ARDS requiring prone ventilation

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Department of Critical Care Medicine, SGPGIMS

Lucknow, Uttar Pradesh, 226014, India

Location

Related Links

• Saran S, Gurjar M, Kanaujia V, Ghosh PS, Gupta A, Mishra P, et. al. Effect of Prone Positioning on Intraocular Pressure in Patients With Acute Respiratory Distress Syndrome. Crit Care Med. 2019 Sep;47(9):e761-e766. PMID: 31305498

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Mohan Gurjar, MD, PDCC

  Sanjay Gandhi Postgraduate Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 17, 2016
• Study Start: May 3, 2016
• Primary Completion: July 24, 2017
• Study Completion: October 24, 2017
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)