Skip to main content
OpenTrials
Completed

NCT Number: NCT03031275

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Long Term Adverse Effects Acute Respiratory Distress Syndrome Cognition Disorders Cognitive Dysfunction Cognitive Impairment Critical Illness Disease Attributes Extracorporeal Circulation; Complications Infections Inflammation Lung Diseases Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ECMO Center Karolinska

Stockholm, 17176, Sweden

About this study

All adult patients treated at the ECMO Center Karolinska between 1995 and July 2009 were screened for eligibility in January 2014. Patients living abroad (including non-Swedish citizens), patients treated for non-respiratory conditions, diseased patients and patients with a known pre-ECMO mental handicap were excluded.

Eligible patients were contacted, and patients who agreed to participate gave their written informed consent. All studied patients underwent the same study protocol during a day at the hospital, including a clinical interview, MRI scan of the brain, HRCT scan of the thorax, pulmonary function testing, neuropsychological examination, walking test, self assessment questionnaires for quality of life, anxiety, depression and post-traumatic stress.

Patient charts were reviewed for relevant clinical information, including age, gender, ECMO mode (venovenous or venoarterial), time in hospital, on ECMO, non-ECMO ICU and on mechanical ventilation; preexisting diseases, blood gas values and ventilator settings before initiation of ECMO treatment. Hand written clinical data from the patients´ charts from every hour with ECMO treatment was reviewed for ventilator settings, lung volumes, mean arterial pressure, hemoglobin, lactate and oxygenation parameters during an observation period, which was defined as the first 10 days on ECMO (or the entire treatment period if shorter than 10 days). This information was added to a digital database for the purpose of this study.

At the time of ECMO treatment, arterial hemoglobin oxygen saturation was measured by peripheral pulse oximetry from the right ear, finger or nose. Venous preoxygenator lactate and venous saturation values were used as indicators of sufficient (lactate < 2 mmol l-1 , SvO2 ≥ 70%) or insufficient tissue perfusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

High-resolution computed tomography

Radiation

HRCT of the thorax

Magnetic resonance imaging

Radiation

MRI of the brain

Cognitive testing

Behavioral

Neuropsychological testing

Primary outcomes

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

    Time frame: 5-17 years after treatment

    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.

  2. Number of participants with abnormal brain imaging assessed by magnetic resonance imaging

    Time frame: 5-17 years after treatment

    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.

  3. Number of Participants With Abnormal Pulmonary function

    Time frame: 5-17 years after treatment

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

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

    Time frame: 5-17 years after treatment

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

    Time frame: 5-17 years after treatment

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

    Time frame: 5-17 years after treatment

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

    Time frame: 5-17 years after treatment

  8. Number of participants with signs of a reduced exercise tolerance

    Time frame: 5-17 years after treatment

    6-minute walking test

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

    Time frame: 5-17 years after treatment

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
First posted
Jan 25, 2017
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.