Safety and Efficacy of Emergency On-call Respiratory Physiotherapy Services in the Paediatric Intensive Care Unit
Primary Purpose
Pediatrics, Critical Care, Respiration, Artificial
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Airway clearance intervention
Sponsored by

About this trial
This is an interventional health services research trial for Pediatrics focused on measuring Physical Therapy Modalities, Pediatrics, Critical Care, Respiration, Artificial
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
Sites / Locations
- Great Ormond Street Hospital for Children NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Airway clearance intervention
Airway clearance intervention 2
Arm Description
Non-respiratory on-call physiotherapy treatment using airway clearance techniques
Specialist respiratory physiotherapy intervention using airway clearance techniques
Outcomes
Primary Outcome Measures
Change in respiratory mechanics (compliance measured mL/kg/cmH2O), resistance measured in cmH2O/L/s)
Respiratory compliance and resistance
Secondary Outcome Measures
Force applied during manual techniques (measured in Newtons)
Force measured during the delivery of manual techniques
Full Information
NCT ID
NCT01999426
First Posted
November 14, 2013
Last Updated
November 26, 2013
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
Physiotherapy Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01999426
Brief Title
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
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators
Physiotherapy Research Foundation
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatrics, Critical Care, Respiration, Artificial
Keywords
Physical Therapy Modalities, Pediatrics, Critical Care, Respiration, Artificial
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Airway clearance intervention
Arm Type
Experimental
Arm Description
Non-respiratory on-call physiotherapy treatment using airway clearance techniques
Arm Title
Airway clearance intervention 2
Arm Type
Active Comparator
Arm Description
Specialist respiratory physiotherapy intervention using airway clearance techniques
Intervention Type
Other
Intervention Name(s)
Airway clearance intervention
Intervention Description
Both respiratory and non-respiratory on-call physiotherapists provide similar airway clearance treatments, the precise components and delivery of which will vary between physiotherapists
Primary Outcome Measure Information:
Title
Change in respiratory mechanics (compliance measured mL/kg/cmH2O), resistance measured in cmH2O/L/s)
Description
Respiratory compliance and resistance
Time Frame
15 minutes pre- and up to 1 hour post intervention. Interventions lasted between 2 and 28 minutes)
Secondary Outcome Measure Information:
Title
Force applied during manual techniques (measured in Newtons)
Description
Force measured during the delivery of manual techniques
Time Frame
measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)
Other Pre-specified Outcome Measures:
Title
Respiratory response during intervention
Description
Flow (L/min), Pressure (cmH2O) and Volume (mL/kg) measured during manual lung inflations and manual techniques
Time Frame
measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleanor Main, PhD
Organizational Affiliation
University College London Institute of Child Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janet Stocks, PhD
Organizational Affiliation
University College London, Institute of Child Health
Official's Role
Study Chair
Facility Information:
Facility Name
Great Ormond Street Hospital for Children NHS Foundation Trust
City
London
ZIP/Postal Code
WC1N 3EH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21056170
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.
Results Reference
background
PubMed Identifier
19627684
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.
Results Reference
background
PubMed Identifier
25749495
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.
Results Reference
derived
PubMed Identifier
25749494
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.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of Emergency On-call Respiratory Physiotherapy Services in the Paediatric Intensive Care Unit
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