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

NHS Foundation Trust

Status: Completed

Conditions: Critical Care; Pediatrics; Respiration, Artificial

Treatments: Other: Airway clearance intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01999426

05AR17

PRF/05/1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Airway clearance intervention

Experimental group

Description:

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

Treatment:

Other: Airway clearance intervention

Airway clearance intervention 2

Active Comparator group

Description:

Specialist respiratory physiotherapy intervention using airway clearance techniques

Treatment:

Other: Airway clearance intervention