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

• ClinicalTrials.gov Identifier: NCT03031275
• Recruitment Status: Completed
• First Posted: January 25, 2017
• Last Update Posted: January 25, 2017
• Sponsor: Karolinska University Hospital
• Information provided by (Responsible Party): Bernhard Holzgraefe, Karolinska University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Long Term Adverse Effects; Pneumonia; Acute Respiratory Distress Syndrome; Sepsis; Critical Illness; Cognitive Impairment; Extracorporeal Circulation; Complications	Radiation: High-resolution computed tomography; Radiation: Magnetic resonance imaging; Behavioral: Cognitive testing	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Masking Description: 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).
• Primary Purpose: Other
• Study Start Date: January 2014
• Actual Primary Completion Date: December 2016

Arms and Interventions

Intervention Details:

• Radiation: High-resolution computed tomography
  HRCT of the thorax
• Radiation: Magnetic resonance imaging
  MRI of the brain
• Behavioral: Cognitive testing
  Neuropsychological testing

Outcome Measures

Primary Outcome Measures :

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Sweden

ECMO Center Karolinska

Stockholm, Sweden, 17176

Sponsors and Collaborators

Karolinska University Hospital

More Information

• Responsible Party: Bernhard Holzgraefe, MD, PhD, Karolinska University Hospital
• ClinicalTrials.gov Identifier: NCT03031275
• Other Study ID Numbers: 2013/2258-31/1
• First Posted: January 25, 2017
• Last Update Posted: January 25, 2017
• Last Verified: January 2017

Keywords provided by Bernhard Holzgraefe, Karolinska University Hospital:

extracorporeal circulation; critical care outcomes

Additional relevant MeSH terms:

Pneumonia; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome, Adult; Acute Lung Injury; Critical Illness; Long Term Adverse Effects; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Disease Attributes; Pathologic Processes