Hemodynamic Assessment With Trans-esophageal Doppler (TED) During Prone Ventilation in ARDS Patients

NCT02664090 | Completed

• 1 other identifier: 2015-139-DM-88
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Acute respiratory distress syndrome (ARDS) commonly complicates acute illness in 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. Prone positioning has been reported to have hemodynamic disturbances like hypotension and arrhythmias. The literature till date is unclear with regards to acute hemodynamic changes which can happen during initiation of prone ventilation ,with a few studies suggesting decreasing cardiac output and a few increasing cardiac output. In recent years, trans-esophageal Doppler (TED) has become one of important hemodynamic assessment tool due to its minimal invasiveness, ease of use with its clinical utility established by various studies both in operation theatres and intensive care units. In current study, the investigators would like to evaluate acute hemodynamic effects of prone ventilation with TED in patients of acute respiratory distress syndrome (ARDS).

Conditions

Respiratory Distress Syndrome, Adult

Keywords

acute respiratory distress syndrome; prone ventilation; trans-esophageal doppler

Outcome Measures

Primary Outcomes (1)

• To measure pattern of changes in cardiac index (L/min/m2) from baseline (pre-prone position) to during prone position.

  Baseline (pre-prone) and after initiation of prone-ventilation at 5, 10, 20 and 30 minutes.

Eligibility Criteria

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

Study Population

All critically ill adult patients with diagnosis of ARDS whose hemodynamic monitoring is being done by trans-esophageal doppler (TED), and planned for prone ventilation by treating physician's decision, will be screened for inclusion in this study.

You may qualify if:

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

You may not qualify if:

• Patients with age \<18 years.
• Conditions which can interfere with interpretation of hemodynamic parameters through TED (aortic coarctation, severe aortic stenosis, severe aortic regurgitation, severe scoliosis)
• Pregnant patients

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Department of Critical Care Medicine

Lucknow, Uttar Pradesh, 226014, India

Location

Related Publications (1)

• Saran S, Gurjar M, Azim A, Mishra P, Ghosh PS, Baronia AK, Poddar B, Singh RK. Trans-Esophageal Doppler Assessment of Acute Hemodynamic Changes Due to Prone Positioning in Acute Respiratory Distress Syndrome Patients. Shock. 2019 Oct;52(4):e39-e44. doi: 10.1097/SHK.0000000000001290.

  PMID: 30475331 DERIVED

Related Links

• Saran S, Gurjar M, Azim A, Mishra P, Ghosh PS, Baronia AK, et. al. Trans-Esophageal Doppler Assessment of Acute Hemodynamic Changes Due to Prone Positioning in Acute Respiratory Distress Syndrome Patients. Shock. 2019 Oct;52(4):e39-e44. PMID:30475331

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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 26, 2016
• Study Start: January 20, 2016
• Primary Completion: January 18, 2017
• Study Completion: January 18, 2017
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

IN (1)