Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure

NCT03031275 | Completed

• 1 other identifier: 2013/2258-31/1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center Karolinska. Patients: adult survivors treated with ECMO for severe refractory respiratory failure at least 5 years earlier. Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary function testing, exercise tolerance, quality of life and mood disorder screening.

Conditions

Long Term Adverse Effects; Pneumonia; Acute Respiratory Distress Syndrome; Sepsis; Critical Illness; Cognitive Impairment; Extracorporeal Circulation; Complications

Keywords

extracorporeal circulation; critical care outcomes

Outcome Measures

Primary Outcomes (9)

• Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests

  Wechsler Adult Intelligence Scale, 4th ed, Rey Auditory Verbal Learning Test (learning trials 1 to 5 and delayed recall), immediate recall from the Rey Complex Figure and Logical Memory I and II from Wechsler Memory Scale, 3rd ed.

  5-17 years after treatment

• Number of participants with abnormal brain imaging assessed by magnetic resonance imaging

  Sagittal and axial T1- and T2-weighted images, and coronal T2-weighted and T2-weighted fluid attenuated inversion recovery (FLAIR) images. Slice thickness 4 mm. Presence of hypoxic or anoxic damage, infarctions, hemorrhages, and contusion damage were described.

  5-17 years after treatment

• Number of Participants With Abnormal Pulmonary function

  Static and dynamic spirometry. Measured results as % of the expected normal values were presented.

  5-17 years after treatment

• Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan

  Non-contrast spiral scan. A series for grading of pulmonary changes was reconstructed, using a high spatial resolution reconstruction algorithm with 1 mm-width, overlapping slices. Four patterns were mapped: reticular, ground-glass opacification, consolidation and decreased attenuation.

  5-17 years after treatment

• Number of participants with signs of post-traumatic stress assessed by the Trauma Screening Questionnaire

  5-17 years after treatment

• Number of participants with signs of a reduced health related quality-of-life, assessed by the Short Form-36

  5-17 years after treatment

• Number of participants with signs of a reduced Health related quality-of-life, assessed by the S:t George´s Respiratory Questionnaire

  5-17 years after treatment

• Number of participants with signs of a reduced exercise tolerance

  6-minute walking test

  5-17 years after treatment

• Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale

  5-17 years after treatment

Interventions

High-resolution computed tomography RADIATION

HRCT of the thorax

Magnetic resonance imaging RADIATION

MRI of the brain

Cognitive testing BEHAVIORAL

Neuropsychological testing

Eligibility Criteria

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

You may qualify if:

• Adult patients treated with ECMO at the ECMO Center Karolinska 1995 - July 2009

You may not qualify if:

• Diseased patients
• Patients living abroad (including non-Swedish citizens)
• Patients treated for non-respiratory conditions
• Patients with a known pre-ECMO mental handicap

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

ECMO Center Karolinska

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Long Term Adverse Effects; Pneumonia; Respiratory Distress Syndrome; Sepsis; Critical Illness; Cognitive Dysfunction

Interventions

Magnetic Resonance Spectroscopy; Neuropsychological Tests

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All investigators (radiologist, neuropsychologist, physiotherapist) were masked from all patient details other than the fact that they were treated with ECMO (ie did not know when the patient was treated, for what condition, if any side effects were seen and so on).
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 25, 2017
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

SE (1)