Metabolic Cost of IMT

NCT05101850 | Completed

• 1 other identifier: 298839
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation is a life-saving intervention used worldwide. Despite this, critically ill patients who undergo mechanical ventilation commonly develop muscle weakness; this includes limb muscle weakness and diaphragmatic weakness. Physiotherapy interventions on critically ill patients include; mobilisation to improve limb muscle strength and function, and inspiratory muscle training which aims to target the diaphragm and accessory inspiratory muscles with the goal of improving endurance and strength. Whilst these interventions are standard practice in intensive care, little is known about the physiological load imposed on patients. The purpose of this study is to assess the feasibility of using indirect calorimetry (measured using the Beacon Caresystem) to measure the metabolic cost (oxygen consumption \[VO2\] and carbon dioxide production \[VCO2\]) of inspiratory muscle training and physical rehabilitation in mechanically ventilated intensive care patients.

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (3)

• Recruitment

  The number of patients recruited to the trial compared to the number of eligible patients within the recruitment window

  Through study completion, 9 months

• Adherence to IMT

  The adherence to the prescribed IMT protocol, including reasons for non-adherence

  Throughout the trial period of each participant whilst enrolled i study

• Prevalence of technical issues with relation to the Beacon Caresystem

  Defined as inability to calibrate before intervention, missing data during interventions, inability to analyse data from interventions.

  Through study completion, 9 months

Secondary Outcomes (4)

• Assessment of VO2 and VCO2 in ICU patients at rest

  60 minutes before physical rehabilitation or inspiratory muscle training

• Comparison of VO2 and VCO2 during IMT at different percentages of PImax within and between patients

  During inspiratory muscle training and for 30 minutes after inspiratory muscle training has ceased

• Prevalence of low PImax in patients receiving mechanical ventilation and PImax change during course of their admission

  Day 0 (baseline) and every 5 days whilst the participant is enrolled in the study

• Comparison of VO2 and VCO2 during physical rehabilitation in patients receiving mechanical ventilation

  During physical rehabilitation and for 30 minutes after physical rehabilitation has ceased

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients

You may qualify if:

• Patient invasively ventilated for ≥ 72 hours
• Have an endotracheal tube or tracheostomy in situ
• Respiratory rate of ≤ 35 breaths/min
• Fraction Inspired Oxygen (Fi02) ≤ 0.50
• Co-operative and able to participate in physical rehabilitation and inspiratory muscle training
• Age ≥ 18 years
• Patient consent or, in the case that the patient is unable, advice from the next of kin and acceptance of oral and written information describing the study.

You may not qualify if:

• Undrained pneumothorax/pneumomediastinum
• The absence of an arterial catheter for blood sampling at study start
• Unlikely to survive
• Pregnancy
• Consultant discretion that patient is not appropriate

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Aalborg University: collaborator

Study Sites (1)

The Royal Brompton and Harefield Hospitals

London, SW6 3NP, United Kingdom

Location

Related Publications (2)

• Jenkins TO, Karbing DS, Rees SE, Poulsen MK, Patel BV, Polkey MI, MacBean V. Metabolic cost of physical rehabilitation in mechanically ventilated patients in critical care: an observational study. BMJ Open Respir Res. 2025 Apr 5;12(1):e002878. doi: 10.1136/bmjresp-2024-002878.

  PMID: 40187744 DERIVED

• Jenkins TO, MacBean V, Poulsen MK, Karbing DS, Rees SE, Patel BV, Polkey MI. The metabolic cost of inspiratory muscle training in mechanically ventilated patients in critical care. Intensive Care Med Exp. 2023 Jul 7;11(1):41. doi: 10.1186/s40635-023-00522-6.

  PMID: 37415048 DERIVED

Study Officials

• Micheal Polkey, PhD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: November 1, 2021
• Study Start: October 18, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)