Clinical trial NCT01999426: Safety and Efficacy of Emergency On-call Respiratory Physiotherapy Services in the Paediatric Intensive Care Unit
Official title: Safety and Efficacy of Emergency On-call Respiratory Physiotherapy Services in the Paediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatrics
Critical Care
Respiration, Artificial
Keywords: Physical Therapy Modalities
Pediatrics
Critical Care
Respiration, Artificial
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Physiotherapy Research Foundation
First posted: 2013-12-03
Enrollment: 93
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.


Eligibility 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

Primary outcomes:
measure: Change in respiratory mechanics (compliance measured mL/kg/cmH2O), resistance measured in cmH2O/L/s)
timeFrame: 15 minutes pre- and up to 1 hour post intervention. Interventions lasted between 2 and 28 minutes)
Secondary outcomes:
measure: Force applied during manual techniques (measured in Newtons)
timeFrame: measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)
Other outcomes:
measure: Respiratory response during intervention
timeFrame: measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Foundation Trust
Study officials:
affiliation: University College London Institute of Child Health
name: Eleanor Main, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University College London, Institute of Child Health
name: Janet Stocks, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: Shannon H, Stocks J, Gregson RK, Dunne C, Peters MJ, Main E. Clinical effects of specialist and on-call respiratory physiotherapy treatments in mechanically ventilated children: A randomised crossover trial. Physiotherapy. 2015 Dec;101(4):349-56. doi: 10.1016/j.physio.2014.12.004. Epub 2015 Jan 18.
citation: Shannon H, Stocks J, Gregson RK, Hines S, Peters MJ, Main E. Differences in delivery of respiratory treatments by on-call physiotherapists in mechanically ventilated children: a randomised crossover trial. Physiotherapy. 2015 Dec;101(4):357-63. doi: 10.1016/j.physio.2014.12.001. Epub 2015 Jan 17.