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Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling.

ABSTRACT: Induction methods for therapeutic cooling are under investigated. We compared the effectiveness and safety of cold infusions (CI) and nasopharyngeal cooling (NPC) for cooling induction in stroke patients.A prospective, open-label, randomised (1:1), single-centre pilot trial with partially blinded safety endpoint assessment was conducted at the neurointensive care unit of Heidelberg University. Intubated stroke patients with an indication for therapeutic cooling and an intracranial pressure (ICP)/temperature brain probe were randomly assigned to CI (4°C, 2L at 4L/h) or NPC (60L/min for 1 h). Previous data suggested a maximum decrease of tympanic temperature for CI (2.1L within 35 min) after 52 min. Therefore the study period was 1 hour (15 min subperiods I-IV). The brain temperature course was the primary endpoint. Secondary measures included continuous monitoring of neurovital parameters and extracerebral temperatures. Statistical analysis based on repeated-measures analysis of variance.Of 221 patients screened, 20 were randomized within 5 months. Infusion time of 2L CI was 33?±?4 min in 10 patients and 10 patients received NPC for 60 min. During active treatment (first 30 min), brain temperature decreased faster with CI than during NPC (I: -0.31 ± 0.2 versus -0.12 ± 0.1°C, P = 0.008; II: -1.0 ± 0.3 versus -0.49 ± 0.3°C, P = 0.001). In the CI-group, after the infusion was finished, the intervention no longer decreased brain temperature, which increased after 3.5?±?3.3 min. Oesophageal temperature correlated best with brain temperature during CI and NPC. Tympanic temperature reacted similarly to relative changes of brain temperature during CI, but absolute values slightly differed. CI provoked three severe adverse events during subperiods II-IV (two systolic arterial pressure (SAP), one shivering) compared with four in the NPC-group, all during subperiod I (three SAP, one ICP). Classified as possibly intervention-related, two cases of ventilator failure occurred during NPC.In intubated stroke patients, brain cooling is faster during CI than during NPC. Importantly, contrary to previous expectations, brain cooling stopped soon after CI cessation. Oesophageal but neither bladder nor rectal temperature is suited as surrogate for brain temperature during CI and NPC. Several severe adverse events in CI and in NPC demand further studying of safety.ClinicalTrials.gov NCT01573117. Registered 31 March 2012.

SUBMITTER: Poli S

PROVIDER: S-EPMC4234831 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling.

Poli Sven S Purrucker Jan J Priglinger Miriam M Ebner Matthias M Sykora Marek M Diedler Jennifer J Bulut Cem C Popp Erik E Rupp André A Hametner Christian C

Critical care (London, England) 20141027 5

<h4>Introduction</h4>Induction methods for therapeutic cooling are under investigated. We compared the effectiveness and safety of cold infusions (CI) and nasopharyngeal cooling (NPC) for cooling induction in stroke patients.<h4>Methods</h4>A prospective, open-label, randomised (1:1), single-centre pilot trial with partially blinded safety endpoint assessment was conducted at the neurointensive care unit of Heidelberg University. Intubated stroke patients with an indication for therapeutic cooli ...[more]

PMID: 25346332

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Project description:PurposeProximal hamstring tendinopathy (PHT) presents as localised lower buttock pain with tasks such as squatting and sitting. It is a condition that occurs at all ages and levels of sporting participation and can cause disability with sport, work, and activities of daily living. This paper details a pilot trial protocol for investigating the effectiveness of individualised physiotherapy compared to extracorporeal shockwave therapy (ESWT) on pain and strength in people with PHT.MethodsThe study is an assessor-blinded, pilot randomised controlled trial (RCT). One hundred participants with PHT will be recruited from the local community and sporting clubs. Participants will be randomised to receive six sessions of either individualised physiotherapy or ESWT, with both groups also receiving standardised education and advice. Primary outcomes will be global rating of change on a 7-point Likert scale, and the Victorian Institute of Sport-Hamstring (VISA-H) scale, measured at 0, 4, 12, 26 and 52 weeks. Secondary outcomes will include sitting tolerance, the modified Physical Activity Level Scale, eccentric hamstring strength, modified Tampa scale for kinesiophobia, the Örebro Musculoskeletal Pain Screening Questionnaire Short Form (ÖMPSQ-SF), Numerical Pain Rating Scale (NPRS) for average and worst pain, participant adherence, the Pain Catastrophizing scale, satisfaction scores, and quality of life. Data will be analysed on an intention to treat basis, with between-group effects estimated using linear mixed models for continuous data and Mann Whitney U tests for ordinal data.ConclusionsThis pilot RCT will compare individualised physiotherapy versus ESWT for PHT. The trial will determine feasibility and estimated treatment effects to inform a definitive trial in the future.Trial registrationThe trial has been prospectively registered with the Australia & New Zealand Clinical Trials Registry (ACTRN12621000846820), registered 1 July 2021, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373085.

Project description:IntroductionThe Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design.Methods and analysisA 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9 months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis.Ethics and disseminationNational Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised Trainer and Intervention Delivery manuals for multicentre replication of ReTrain; presentations at conferences, public involvement events; internationally recognised peer-reviewed journal publications, open access sources and media releases.Trial registration numberNCT02429180; Pre-results.

Dataset Information

Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling.

Publications

Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling.

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