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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Sepsis; Critical Illness; Cognitive Impairment; Acute Respiratory Distress Syndrome; Extracorporeal Circulation; Complications; Long Term Adverse Effects
• Intervention / Treatment: Radiation: High-resolution computed tomography; Radiation: Magnetic resonance imaging; Behavioral: Cognitive testing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • ECMO Center Karolinska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 22, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Estimate): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 22, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: extracorporeal circulation; critical care outcomes
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Critical Illness; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Long Term Adverse Effects
• Other Study ID Numbers: 2013/2258-31/1