Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01999426
Study type Interventional
Source Great Ormond Street Hospital for Children NHS Foundation Trust
Contact
Status Completed
Phase N/A
Start date July 2006
Completion date August 2009

See also
  Status Clinical Trial Phase
Recruiting NCT05114551 - ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
Completed NCT05547646 - The Prevalence of Healthcare-associated Infection in Medical Intensive Care Units in Tunisia
Recruiting NCT03697785 - Weaning Algorithm for Mechanical VEntilation N/A
Completed NCT02922101 - Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care N/A
Completed NCT02902783 - DONATE-Pilot Study on ICU Management of Deceased Organ Donors
Completed NCT01885442 - TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients N/A
Completed NCT01857986 - Evaluating Air Leak Detection in Intubated Patients N/A
Recruiting NCT05518955 - VR Integrated Into Multicomponent Interventions for Improving Sleep in ICU N/A
Recruiting NCT03810768 - Metabolomics Study on Postoperative Intensive Care Acquired Muscle Weakness
Completed NCT03295630 - Validity of an Actigraph Accelerometer Following Critical Illness N/A
Completed NCT05556811 - HEaling LIght Algorithms for the ICU Patient N/A
Recruiting NCT05702411 - Air Stacking Technique For Pulmonary Reexpansion N/A
Completed NCT02741453 - Bilateral Internal Jugular Veins Ultrasound Scanning Prior to CVC Placement N/A
Recruiting NCT04979897 - Impact on Mental, Physical, And Cognitive Functioning of a Critical Care sTay During the COVID-19 Pandemic
Completed NCT05281224 - Ventilator Tube Holder for Patients With a Tracheostomy
Withdrawn NCT02970903 - VitalPAD: an Intelligent Monitoring and Communication Device to Optimize Safety in the PICU N/A
Recruiting NCT02587273 - The Pharmacokinetics of Fentanyl in Intensive Care Patients Phase 4
Completed NCT02661607 - Point of Care Echocardiography Versus Chest Radiography for the Assessment of Central Venous Catheter Placement N/A
Completed NCT01479153 - Venous Site for Central Catheterization N/A
Recruiting NCT06110390 - High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients N/A