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

Critical Care Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01999426
• Other study ID #: 05AR17
• Secondary ID: PRF/05/1
• Status: Completed
• Phase: N/A
• First received: November 14, 2013
• Last updated: November 26, 2013
• Start date: July 2006
• Est. completion date: August 2009

Study information

• Verified date: November 2013
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Critical Care
• Pediatrics
• Respiration, Artificial

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust	Physiotherapy Research Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

Shannon H, Stiger R, Gregson RK, Stocks J, Main E. Effect of chest wall vibration timing on peak expiratory ?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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Primary	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)	No
Secondary	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)	No