MIND Score for Prolonged Mechanical Ventilation

NCT02255058 | Completed

• 1 other identifier: Linde001
• Study Type: observational
• Target: 129
• Locations: 3 countries
• Sites: 5

Brief Summary

It was decided to develop a comprehensive disability score specifically designed for patients receiving prolonged mechanical ventilation (PMV); the collection of information included in the score should not impose any further intervention beyond what is routinely performed. So a new questionnaire was created (called the Multi-INdependency Dimensions (MIND) that included 3 sections (nurse, physiotherapist and medical doctor), 11 categories and 18 items. Each question was adapted to have a 5 item Likert scale. The primary objective of the study will be to evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time. The secondary objective will be to assess the inclusion of biological markers on the overall performance of the MIND score

Conditions

Functional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, Disability

Outcome Measures

Primary Outcomes (1)

• To evaluate the psychometric performance of the MIND score in terms of validity, reliability and sensitivity to change over time

  6 Months

Secondary Outcomes (1)

• To assess the inclusion of biological markers on the overall performance of the MIND score

  6 Months

Interventions

No intervention OTHER

The study is a Prospective observational cohort study

Eligibility Criteria

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

Study Population

Adult patients with Prolonged mechanical Ventilation and a Diagnosis of Acute lung injury, COPD/Chronic Lung Disease, Neuromuscular Disorders, Post-Operative, Cardiovascular Disorders, Trauma, Other.

You may qualify if:

• Adult patients with Prolonged mechanical Ventilation and a Diagnosis of Acute lung injury, COPD/Chronic Lung Disease, Neuromuscular Disorders, Post-Operative, Cardiovascular Disorders, Trauma, Other.

You may not qualify if:

• Expected length of stay \<48h, unable to achieve consent

Sponsors & Collaborators

• Linde AG: lead

Study Sites (5)

REMEO El Pilar

Buenos Aires, Argentina

Location

REMEO Bogota

Bogotá, Colombia

Location

REMEO Medellin

Medellín, Colombia

Location

REMEO Centre

Berlin, Germany

Location

REMEO Mahlow

Berlin, Germany

Location

Related Publications (1)

• Winck JC, Gilet H, Kalin P, Murcia J, Plano F, Regnault A, Dreher M, Vitacca M, Ambrosino N. Validation of the Multi-INdependence Dimensions (MIND) questionnaire for prolonged mechanically ventilated subjects. BMC Pulm Med. 2019 Jun 20;19(1):109. doi: 10.1186/s12890-019-0870-2.

  PMID: 31221129 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• Joao C Winck, MD,PhD

  Linde AG, Global Business Unit Healthcare

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 2, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 2, 2015

Record last verified: 2014-10

Locations

CO (2); DE (2); AR (1)