Safety and Efficacy of Emergency On-call Respiratory Physiotherapy Services in the Paediatric Intensive Care Unit

Study Overview
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Brief Summary
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Emergency on-call respiratory physiotherapy cover for children in intensive care is frequently provided by physiotherapists who ordinarily work in non-respiratory areas. This has produced concerns about the safety and efficacy of on-call treatments and is widely recognised as an important clinical governance issue affecting services throughout the National Health Service (NHS). The aim of this study is to investigate whether emergency on-call respiratory physiotherapy services provided in the paediatric intensive care unit (ICU) are safe and effective. Further it will explore whether there are any quantifiable differences between specialist and on-call physiotherapy treatments. The study is a randomised, cross-over study design. Infants and children who are likely to require at least 2 physiotherapy treatments in one day are recruited to the study. Both physiotherapy airway clearance treatments are administered during a 12 hour period, with at least 2 hours between treatments. One is administered by a respiratory physiotherapist who works regularly in the ICU and one by a physiotherapist on the on-call rota, who normally practises in a non-respiratory clinical area. Treatments are performed in a randomised order and outcomes measured before, during and after treatments. Physiotherapy staff who consent to participate in the study include: Specialist respiratory physiotherapists who regularly work in the ICU Non-respiratory physiotherapists on the on-call rota who normally work in a non-respiratory areas but cover the ICU overnight and at weekends. Patients include: the study aims to recruit 80 infants and children (ages 0 to 16 years), who are in the paediatric intensive care unit and Require full mechanical ventilation and are well sedated Are likely to require at least two physiotherapy treatments within the day of the study (assessed by an independent senior respiratory physiotherapist) and Whose parents or carers consent for them to participate in the study. Respiratory mechanics, arterial blood gases, oxygen saturation and peak pressures are recorded before and after each intervention Forces applied during manual techniques, flow, pressure and volume during manual lung inflations, volume of saline and selection and order of treatment components are recorded during treatments Adverse events occurring during or up to 30 minutes after physiotherapy are also recorded.

Official Title
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Safety and Efficacy of Emergency On-call Respiratory Physiotherapy Services in the Paediatric Intensive Care Unit

Conditions
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Pediatrics, Critical Care, Respiration, Artificial

Intervention / Treatment
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* Other: Airway clearance intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infants and children who are well sedated and mechanically ventilated and likely to require at least 2 physiotherapy interventions over the course of a single day Exclusion Criteria: patients in whom the application of manual techniques is contra-indicated

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Airway clearance intervention<br>Non-respiratory on-call physiotherapy treatment using airway clearance techniques | Other: Airway clearance intervention<br>* Both respiratory and non-respiratory on-call physiotherapists provide similar airway clearance treatments, the precise components and delivery of which will vary between physiotherapists<br>|
| Active Comparator: Airway clearance intervention 2<br>Specialist respiratory physiotherapy intervention using airway clearance techniques | Other: Airway clearance intervention<br>* Both respiratory and non-respiratory on-call physiotherapists provide similar airway clearance treatments, the precise components and delivery of which will vary between physiotherapists<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in respiratory mechanics (compliance measured mL/kg/cmH2O), resistance measured in cmH2O/L/s) | Respiratory compliance and resistance | 15 minutes pre- and up to 1 hour post intervention. Interventions lasted between 2 and 28 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force applied during manual techniques (measured in Newtons) | Force measured during the delivery of manual techniques | measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Therapy Modalities, Pediatrics, Critical Care, Respiration, Artificial