Safety and Efficacy of Emergency On-call Respiratory Physiotherapy Services in the Paediatric Intensive Care Unit
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Airway clearance intervention Non-respiratory on-call physiotherapy treatment using airway clearance techniques |
Other: Airway clearance intervention
Both respiratory and non-respiratory on-call physiotherapists provide similar airway clearance treatments, the precise components and delivery of which will vary between physiotherapists
|
| Active Comparator: Airway clearance intervention 2 Specialist respiratory physiotherapy intervention using airway clearance techniques |
Other: Airway clearance intervention
Both respiratory and non-respiratory on-call physiotherapists provide similar airway clearance treatments, the precise components and delivery of which will vary between physiotherapists
|
Outcome Measures
Primary Outcome Measures
- Change in respiratory mechanics (compliance measured mL/kg/cmH2O), resistance measured in cmH2O/L/s) [15 minutes pre- and up to 1 hour post intervention. Interventions lasted between 2 and 28 minutes)]
Respiratory compliance and resistance
Secondary Outcome Measures
- Force applied during manual techniques (measured in Newtons) [measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)]
Force measured during the delivery of manual techniques
Other Outcome Measures
- Respiratory response during intervention [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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Great Ormond Street Hospital for Children NHS Foundation Trust | London | United Kingdom | WC1N 3EH |
Sponsors and Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Physiotherapy Research Foundation
Investigators
- Principal Investigator: Eleanor Main, PhD, University College London Institute of Child Health
- Study Chair: Janet Stocks, PhD, University College London, Institute of Child Health
Study Documents (Full-Text)
None provided.More Information
Publications
- Shannon H, Gregson R, Stocks J, Cole TJ, Main E. Repeatability of physiotherapy chest wall vibrations applied to spontaneously breathing adults. Physiotherapy. 2009 Mar;95(1):36-42. doi: 10.1016/j.physio.2008.08.004. Epub 2008 Oct 1.
- Shannon H, Stiger R, Gregson RK, Stocks J, Main E. Effect of chest wall vibration timing on peak expiratory fl ow and inspiratory pressure in a mechanically ventilated lung model. Physiotherapy. 2010 Dec;96(4):344-9. doi: 10.1016/j.physio.2010.02.007. Epub 2010 Apr 21.
- 05AR17
- PRF/05/1