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

NCT01999426 | Completed

• 2 other identifiers: 05AR17PRF/05/1
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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. 1.Require full mechanical ventilation and are well sedated
2. 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. 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.

Conditions

Pediatrics; Critical Care; Respiration, Artificial

Keywords

Physical Therapy Modalities; Pediatrics; Critical Care; Respiration, Artificial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Force applied during manual techniques (measured in Newtons)

  measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)

Other Outcomes (1)

• Respiratory response during intervention

  measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)

Study Arms (2)

Airway clearance intervention

EXPERIMENTAL

Non-respiratory on-call physiotherapy treatment using airway clearance techniques

Other: Airway clearance intervention

Airway clearance intervention 2

ACTIVE COMPARATOR

Specialist respiratory physiotherapy intervention using airway clearance techniques

Other: Airway clearance intervention

Interventions

Airway clearance intervention OTHER

Both respiratory and non-respiratory on-call physiotherapists provide similar airway clearance treatments, the precise components and delivery of which will vary between physiotherapists

Airway clearance intervention; Airway clearance intervention 2

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• patients in whom the application of manual techniques is contra-indicated

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• Physiotherapy Research Foundation: collaborator

Study Sites (1)

Great Ormond Street Hospital for Children NHS Foundation Trust

London, WC1N 3EH, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 21056170 BACKGROUND

• 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.

  PMID: 19627684 BACKGROUND

• 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.

  PMID: 25749495 DERIVED

• 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.

  PMID: 25749494 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eleanor Main, PhD

  University College London Institute of Child Health

  PRINCIPAL INVESTIGATOR

• Janet Stocks, PhD

  University College London, Institute of Child Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2013
• First Posted: December 3, 2013
• Study Start: July 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 3, 2013

Record last verified: 2013-11

Locations

GB (1)