Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3EH, United Kingdom
NCT Number: NCT01999426
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
1. Require full mechanical ventilation and are well sedated 2. Are likely to require at least two physiotherapy treatments within the day of the study (assessed by an independent senior respiratory physiotherapist) and 3. 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.
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Notify MeUp to 16 year
All sexes
Interventional
Not applicable
London, WC1N 3EH, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Both respiratory and non-respiratory on-call physiotherapists provide similar airway clearance treatments, the precise components and delivery of which will vary between physiotherapists
Time frame: 15 minutes pre- and up to 1 hour post intervention. Interventions lasted between 2 and 28 minutes)
Respiratory compliance and resistance
Time frame: measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)
Force measured during the delivery of manual techniques
Time frame: measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)
Flow (L/min), Pressure (cmH2O) and Volume (mL/kg) measured during manual lung inflations and manual techniques
Great Ormond Street Hospital for Children NHS Foundation Trust
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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