Effect of Altitude on the Evolution of Acute Respiratory Distress Syndrome

NCT02871063 | Completed

• 1 other identifier: RELAMI ALTURA 001
• Study Type: observational
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this piece of research is to assess the effect of altitude on the clinical evolution of ARDS. For this purpose, patients who live and receive care at sea level are compared with those who live and receive care at high altitudes. For reasons of convenience, a cut-point of 1500 meters above sea level was chosen. In addition to this, it will be sought to assess whether adjusting the cut-points for the severity categories of ARDS improves the ability to predict some adverse events, by comparison with unadjusted cut-points. The results of this research will probably be disruptive, and will provide the first information yet about the effect of altitude on ARDS; they will therefore be of great interest for the international scientific community and for the direct care of patients. A high bibliometric impact is to be expected.

Conditions

ARDS; Hypoxia, Altitude; Altitude Sickness/Epidemiology

Outcome Measures

Primary Outcomes (1)

• Incidence of Acute respiratory distress syndrome (ARDS)

  1 month

Secondary Outcomes (3)

• Duration of mechanical ventilation of patients with Acute respiratory distress syndrome (ARDS)

  1 month

• Length of ICU stay of patients with Acute respiratory distress syndrome (ARDS)

  1 month

• Mortality of Acute respiratory distress syndrome (ARDS)

  1 month

Study Arms (2)

High altitude ARDS

ARDS diagnosed at altitudes greater than 1500 meters above sea level

Sea level ARDS

ARDS diagnosed at altitudes below 1500 meters above sea level

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ARDS patients diagnosed at altitudes greater than 1500 meters above sea level and those of cases diagnosed at altitudes below 1500 meters above sea level

You may qualify if:

• Berlin definition of ARDS
• Pa02/FiO2 ≤ 300 (not corrected for altitude)
• Invasive mechanical ventilation
• Age \>16 years
• Informed consent
• The patient stayed at the same altitude for at least 40 days prior to ICUadmission

You may not qualify if:

• Pregnancy
• Under 16 years
• Not accept informed consent

Sponsors & Collaborators

• Guillermo Ortiz Ruiz: lead

Related Publications (1)

• Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.

  PMID: 26903337 BACKGROUND

Related Links

• RELAMI WEB SITE

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD(c)

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 18, 2016
• Study Start: August 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 4, 2017

Record last verified: 2017-10