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

Not Applicable

Completed

• Conditions: Pediatrics; Critical Care; Respiration, Artificial
• Interventions: Other: Airway clearance intervention

• Registration Number: NCT01999426
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2013-11
• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-26
• Last Update Submitted: 2013-11-26
• Study First Posted: 2013-12-03
• Last Update Posted: 2013-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Airway clearance intervention	Airway clearance intervention	Non-respiratory on-call physiotherapy treatment using airway clearance techniques
Airway clearance intervention 2	Airway clearance intervention	Specialist respiratory physiotherapy intervention using airway clearance techniques

Primary Outcome Measures

Name	Time	Method
Change in respiratory mechanics (compliance measured mL/kg/cmH2O), resistance measured in cmH2O/L/s)	15 minutes pre- and up to 1 hour post intervention. Interventions lasted between 2 and 28 minutes)	Respiratory compliance and resistance

Secondary Outcome Measures

Name	Time	Method
Force applied during manual techniques (measured in Newtons)	measured during intervention (which lasted between 2 and 28 minutes, average 8 minutes)	Force measured during the delivery of manual techniques

Trial Locations

Locations (1)

Great Ormond Street Hospital for Children NHS Foundation Trust; 🇬🇧 London, United Kingdom