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

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.

Study Overview

• Status: Completed
• Conditions: Critical Care; Respiration, Artificial; Pediatrics
• Intervention / Treatment: Other: Airway clearance intervention

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3EH
    • Great Ormond Street Hospital For Children NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory response during intervention	Flow (L/min), Pressure (cmH2O) and Volume (mL/kg) measured during manual lung inflations and manual techniques	measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)

Collaborators and Investigators

• Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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, 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: November 14, 2013
• First Submitted That Met QC Criteria: November 26, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Pediatrics; Physical Therapy Modalities; Critical Care; Respiration, Artificial
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 05AR17; PRF/05/1 (Other Grant/Funding Number: Physiotherapy Research Foundation)