Identifying and Understanding Risk Factors for Instability and Adverse Events Associated With Chest Physiotherapy in Ventilated Children

NCT04146753 | Completed

• 1 other identifier: 18BA19
• Study Type: observational
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

Paediatric intensive care units support the complex medical needs of children with life threatening conditions. There are 20000 admissions annually within the United Kingdom and 65% require life support through a breathing machine. Chest physiotherapy is considered part of routine care for these patients. There is a small amount of evidence providing support for the effectiveness of chest physiotherapy however it has been associated with instability and adverse events. At present the risks and benefits of chest physiotherapy in ventilated children are unknown. It is important to identify which patients are likely to benefit most and in which situations chest physiotherapy may present a significant risk. Aim: To identify and understand the risk factors for instability and harmful events which may occur due to chest physiotherapy in children on intensive care. Design/Methods Work Package 1 Phase 1 - An anonymous, electronic survey will be sent to all UK physiotherapists who work in paediatric critical care. Information will be collected about physiotherapy practice, referrals, and risk factors assessed and monitored. Phase 2 - Interviews with 18-27 physiotherapists will take place. The findings from phase 1 will guide the questions. Phase 2 will provide a more in-depth understanding about physiotherapy decision making and management of risks. Work Package 2 This part of the study will quantitatively assess the effects of chest physiotherapy and identify risk factors for instability. Routinely collected data from the three intensive care units at Great Ormond Street Hospital will be used. No contact with patients/families will be required, and no change to care will occur. Data from approximately 1000 patients will be collected over one year. Health related measures (e.g. oxygen levels) will be recorded before and after chest physiotherapy.

Conditions

Respiratory Failure

Keywords

Chest physiotherapy; Paediatric intensive care unit; Physiological instability; Adverse events

Outcome Measures

Primary Outcomes (1)

• Oxygenation

  Work package 2 - Arterial oxygen saturations (SpO2), measured non-invasively by a finger pulse oximeter.

  Change in baseline Sp02 for 30 minutes before chest physiotherapy and 30 minutes after

Secondary Outcomes (3)

• Heart rate

  Change in baseline HR for 30 minutes before chest physiotherapy and 30 minutes

• Mean blood pressure

  Change in baseline HR and MBP for 30 minutes before chest physiotherapy and 30 minutes

• Presence of Adverse Events

  30 minutes after chest physiotherapy

Eligibility Criteria

• Age: 0 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children across three intensive care units at a tertiary childrens hospital

You may qualify if:

• Intubated and mechanically ventilated
• Receiving chest physiotherapy
• years of age
• First four days of mechanical ventilation

You may not qualify if:

• Newborn premature babies (currently \<36 weeks gestation)
• Patients requiring mechanical circulatory support
• Patients not for escalation of care or not receiving active treatment

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• University College, London: collaborator

Study Sites (1)

Great Ormond Street Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Emma Shkurka

  Great Ormond Street Hospital for Children NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 31, 2019
• Study Start: July 29, 2020
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Locations

GB (1)