Intra-operative protective mechanical ventilation in lung transplantation: a randomised, controlled trial

IntroductionSurvivors of critical illness often experience significant morbidities, including muscle weakness and impairments in physical functioning. This muscle weakness is associated with longer duration mechanical ventilation, greater hospital costs and increased postdischarge impairments in physical function, quality of life and survival. Compared with standard of care, the benefits of greater protein intake combined with structured exercise started early after the onset of critical illness remain uncertain. However, the combination of protein supplementation and exercise in other populations has demonstrated positive effects on strength and function. In the present study, we will evaluate the effects of a combination of early implementation of intravenous amino acid supplementation and in-bed cycle ergometry exercise versus a ‘usual care’ control group in patients with acute respiratory failure requiring mechanical ventilation in an intensive care unit (ICU).Methods and analysisIn this multicentre, assessor-blinded, randomised controlled trial, we will randomise 142 patients in a 1:1 ratio to usual care (which commonly consists of minimal exercise and under-achievement of guideline-recommended caloric and protein intake goals) versus a combined intravenous amino acid supplementation and in-bed cycle ergometery exercise intervention. We hypothesise that this novel combined intervention will (1) improve physical functioning at hospital discharge; (2) reduce muscle wasting with improved amino acid metabolism and protein synthesis in-hospital and (3) improve patient-reported outcomes and healthcare resource utilisation at 6 months after enrolment. Key cointerventions will be standardised. In-hospital outcome assessments will be conducted at baseline, ICU discharge and hospital discharge. An intent-to-treat analysis will be used to analyse all data with additional per-protocol analyses.Ethics and disseminationThe trial received ethics approval at each institution and enrolment has begun. These results will inform both clinical practice and future research in the area. We plan to disseminate trial results in peer-reviewed journals, at national and international conferences, and via nutritional and rehabilitation-focused electronic education and knowledge translation platforms.Trial registration numberNCT03021902; Pre-results.

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Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial

Trials ◽

10.1186/s13063-019-4035-7 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Kyeong Tae Kim ◽

Sophie Morton ◽

Sarah Howe ◽

Yeong Shiong Chiew ◽

Jennifer L. Knopp ◽

...

Keyword(s):

Mechanical Ventilation ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Standard Practice ◽

Model Based ◽

Randomised Controlled

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Initiation of home mechanical ventilation at home: A randomised controlled trial of efficacy, feasibility and costs

Respiratory Medicine ◽

10.1016/j.rmed.2014.07.008 ◽

2014 ◽

Vol 108 (9) ◽

pp. 1387-1395 ◽

Cited By ~ 35

Author(s):

A. Hazenberg ◽

H.A.M. Kerstjens ◽

S.C.L. Prins ◽

K.M. Vermeulen ◽

P.J. Wijkstra

Keyword(s):

Mechanical Ventilation ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Home Mechanical Ventilation ◽

Randomised Controlled ◽

At Home

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Avoidance of mechanical ventilation by surfactant treatment of spontaneously breathing preterm infants (AMV): an open-label, randomised, controlled trial

The Lancet ◽

10.1016/s0140-6736(11)60986-0 ◽

2011 ◽

Vol 378 (9803) ◽

pp. 1627-1634 ◽

Cited By ~ 202

Author(s):

Wolfgang Göpel ◽

Angela Kribs ◽

Andreas Ziegler ◽

Reinhard Laux ◽

Thomas Hoehn ◽

...

Keyword(s):

Mechanical Ventilation ◽

Randomised Controlled Trial ◽

Preterm Infants ◽

Controlled Trial ◽

Open Label ◽

Surfactant Treatment ◽

Randomised Controlled ◽

Spontaneously Breathing

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Study protocol for a multicentre randomised controlled trial studying the effect of a music intervention on anxiety in adult critically ill patients (The RELACS trial)

BMJ Open ◽

10.1136/bmjopen-2021-051473 ◽

2021 ◽

Vol 11 (10) ◽

pp. e051473

Author(s):

Ellaha Kakar ◽

Margo Van Mol ◽

Johannes Jeekel ◽

Diederik Gommers ◽

Mathieu van der Jagt

Keyword(s):

Mechanical Ventilation ◽

Randomised Controlled Trial ◽

The Netherlands ◽

Critically Ill ◽

Critically Ill Patients ◽

Controlled Trial ◽

Adult Patients ◽

Music Intervention ◽

Positive Effects ◽

Randomised Controlled

IntroductionAnxiety is common in critically ill patients and has likely become more prevalent in the recent decade due to the imperative of the recent Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients (PADIS) to use low levels of sedation and strive for wakefulness. However, management of anxiety has not been included in the PADIS guidelines, and there is lack of evidence to treat it in spite of its growing importance. Administration of sedative and analgesic medication is often chosen to reduce anxiety, especially when associated with agitation. Sedatives are associated with prolonged mechanical ventilation, delirium and muscle wasting and are therefore preferably minimised. Previous studies have suggested positive effects of music interventions on anxiety in the critically ill. Therefore, we aim to study the effect of music intervention on anxiety in adult critically ill patients.Methods and designA multicentre randomised controlled trial was designed to study the effect of a music intervention on the level of anxiety experienced by adult patients admitted to the intensive care unit (ICU). One hundred and four patients will be included in three centres in the Netherlands. Patient recruitment started on 24-08-2020 and is ongoing in three hospitals. The primary outcome is self-reported anxiety measured on the visual analogue scale. Secondary outcomes include anxiety measured using the six-item State-Trait Anxiety Inventory, sleep quality, agitation and sedation level, medication requirement, pain, delirium, complications, time spend on mechanical ventilation, physical parameters and ICU memory and experience.Ethics and disseminationThe Medical Ethics Review Board of Erasmus MC University Medical Centre Rotterdam, The Netherlands, has approved this protocol. The study is being conducted in accordance with the Declaration of Helsinki. Results of this trial will be published in peer-reviewed scientific journals and conference presentations.Trial registration numberNCT04796389.

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