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PHYSIO+++: protocol for a pilot randomised controlled trial assessing the feasibility of physiotherapist-led non-invasive ventilation for patients with hypoxaemia following abdominal surgery

Por: Hackett · C. · Denehy · L. · Kruger · P. · Ripley · N. · Reid · N. · Smithers · B. M. · Walker · R. M. · Hope · L. · Boden · I.
Introduction

Few clinical trials have investigated physiotherapy interventions to treat hypoxaemia following abdominal surgery. The objective of this study is to determine the feasibility and safety of conducting a clinical trial of physiotherapist-led non-invasive ventilation (NIV).

Methods and analysis

This single-centre, 50-patient, parallel-group, assessor blinded, pilot feasibility randomised controlled trial with concealed allocation will enrol spontaneously ventilating adults with hypoxaemia within 72 hours of major abdominal surgery. Participants will receive either (1) usual care physiotherapy of a single education session (talk), daily walking of 10–15 min (walk) and four sessions of coached deep breathing and coughing (breathe) or (2) usual care physiotherapy plus four 30 min sessions of physiotherapist-led NIV delivered over 2 postoperative days. Primary feasibility and safety outcome measures are; number of eligible patients recruited per week, total time of NIV treatment delivered, acceptability of treatments to patients and clinicians and incidence of adverse events. Secondary feasibility outcomes include measures of recruitment and treatment adherence. Exploratory outcome measures include change in respiratory parameters, postoperative pulmonary complications, length of hospital stay, health-related quality of life, postoperative activity levels and mortality.

Ethics and dissemination

Ethics approval has been obtained from the relevant institution. Results will be published to inform future research.

Trial registration number

ACTRN12622000839707.

Latin American Cerebral Palsy Register (LATAM-CPR): study protocol to develop a collaborative register with surveillance of children with cerebral palsy in Latin American countries

Por: Ruiz Brunner · M. d. l. M. · Jahan · I. · Cuestas · E. · Cieri · M. E. · Escobar Zuluaga · J. · Condinanzi · A. L. · Sanchez · F. · McIntyre · S. · Smithers-Sheedy · H. · Muhit · M. · Badawi · N. · Diaz · R. · Diaz · A. · Carranza · J. · Duran · C. · Quintero Valencia · C. A. · Melarag
Introduction

Cerebral palsy (CP) is one of the leading causes of childhood disability globally with a high burden in low-income and middle-income countries (LMICs). Preliminary findings from the global LMIC CP Register (GLM CPR) suggest that the majority of CP in LMICs are due to potentially preventable causes. Such data are lacking in the Latin American region. Generating comparable epidemiological data on CP from this region could enable translational research and services towards early diagnosis and early intervention. We aim to establish a Latin American multicountry network and online data repository of CP called Latin American Cerebral Palsy Register (LATAM-CPR).

Methods and analysis

The LATAM-CPR will be modelled after the GLM CPR and will support new and emerging Latin American CP registers following a harmonised protocol adapted from the GLM CPR and piloted in Argentina (ie, Argentine Register of Cerebral Palsy). Both population-based and institution-based surveillance mechanisms will be adopted for registration of children with CP aged less than 18 years to the participating CP registers. The data collection form of the LATAM-CPR will include risk factors, clinical profile, rehabilitation, socioeconomical status of children with CP. Descriptive data on the epidemiology of CP from each participating country will be reported, country-specific and regional data will be compared.

Ethics and dissemination

Individual CP registers have applied ethics approval from respective national human research ethics committees (HREC) and/or institutional review boards prior to the establishment and inclusion into the LATAM-CPR. Ethical approval for LATAM-CPR has already been obtained from the HREC in the two countries that started (Argentina and Mexico). Findings will be disseminated and will be made publicly available through peer-reviewed publications, conference presentations and social media communications.

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