Condition category
Respiratory
Date applied
24/06/2020
Date assigned
05/07/2020
Last edited
06/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Reduced breathing muscle performance contributes to the prolonged duration of mechanical ventilation (external breathing machine support) and makes it difficult to come off from the machine. Reduced breathing muscle function also impacts on non-ventilatory functions of the respiratory system including coughing and swallowing function.
We are planning to conduct a study in prolonged ventilated patients(patients on external breathing machine support) to find out the impact of different types of resistance breathing exercises. These are used in some intensive care units to strengthen breathing muscles
worldwide. This study will help us to determine whether this resistance breathing exercises during prolonged ventilation are necessary or not.

Who can participate?
Patients requiring breathing support with a ventilator (external breathing machine) for more than 5 days who are suitable will be included in the study following a discussion with consultant anesthetist and clinical nurse manager.

What does the study involve?
This proposed study plans to monitor and manage breathing muscle dysfunction with multiple tests of strength and endurance and with a dual valve CE marked low-cost device that will be adapted in a novel way to train breathing muscles which help to breathe in and out. Patients will undergo four sets of ten breaths twice a day for two weeks duration with CE marked device. The strength and endurance tests of breathing muscles will be done before and after exercise training.

What are the possible benefits and risks of participating?
Benefits:
The results will help us to determine which exercises help to improve weak respiratory muscle function.
Risks:
There are no anticipated risks with this study. Respiratory assessments are commonly used in physiotherapy. The tests are not invasive. None of the assessments have the potential to cause harm. Different exercises being compared in this study. They are both in line with the intended use of the CE marked device. We will find out from this study if there are any differences between these different exercises in improving respiratory muscle function.

Where is the study run from?
Connolly Hospital Blanchardstown (Ireland)

When is the study starting and how long is it expected to run for?
June 2019 to December 2021

Who is funding the study?
Anglia Ruskin University (UK)

Who is the main contact?
Mr Atchuta Kishore Kothapalli, kishore.kothapalli@hse.ie

Trial website

Contact information

Type

Scientific

Primary contact

Mr Atchuta Kishore Kothapalli

ORCID ID

http://orcid.org/0000-0002-0728-454X

Contact details

Connolly Hospital
Blanchardstown
Physiotherapy Department
Dublin
D15 X40D
Ireland
+353 16465296
kishore.kothapalli@hse.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Comparing effectiveness REspiratory Muscle Dysfunction Interventions IMT versus RMT study in prolonged ventilated patients

Acronym

REMDI

Study hypothesis

Can respiratory (inspiratory and expiratory) muscle training be feasible and more effective compared to inspiratory muscle training alone in prolonged ventilated patients?

Ethics approval

Approved 18/06/2019, Ethics Committee (Connolly Hospital Blanchardstown, Dublin 15, D15 X40D, Republic of Ireland; +353 18213844; nancy.mcguirk@hse.ie), ref: none provided

Study design

Interventional randomized parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Respiratory muscle dysfunction in prolonged ventilated patients

Intervention

Participants will either receive:
1. 2 weeks of inspiratory muscle training, or
2. 2 weeks of both expiratory and inspiratory muscle training

The same CE marked device is set at 50% threshold to train either:
1. Maximum inspiratory pressure (MIP), or
2. Both MIP and Maximum Expiratory Pressure (MEP). Both groups will undergo four sets of ten breaths twice a day for two weeks

Randomisation. To minimise selection bias during randomisation the physiotherapist who is not involved in the study and will have no interaction with any of the trial participants will randomise with concealed randomisation and will have no interaction with any of the trial participants.

There are two data collection points 1) at baseline and 2) at 2 weeks after exercise

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Maximum Inspiratory Pressure (MIP) measured using CE marked Micro RPM (Respiratory Pressure Monitor) at pre-(baseline) and post-intervention (2 weeks). 3 trials are taken and the highest value will be used.

Secondary outcome measures

Measures will be performed pre-(baseline) and post-intervention (2 weeks):
1. Maximum Expiratory Pressure (MEP) will be measured using a pressure manometer - 3 trials are taken and the highest value will be used
2. Cough strength will be measured using a semi-quantitative cough strength score
3. Fatigue resistance index will be measured using the ratio of MIP, post-training with Inspiratory Muscle Trainer/MIP pre-training.
4. Rectus abdominis muscle thickness assessment will be measured using a diagnostic ultrasound machine
5. Hand dynamometry will be measure peripheral muscle function – 3 trials are taken on the participants dominant hand and the highest value will be used

Overall trial start date

18/06/2019

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult patients 18 years or above admitted to general critical care unit and required mechanical ventilation support for more than five days
2. Patients who can respond to the verbal command and can tolerate breathing exercises such as “deep breath in and out”
3. Richmond Agitation-Sedation Scale score 0

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Medically unstable during critical care admission and prolonged ventilation period before training
2. Use of more than minimal continuous infusion inotropic agents
3. Contraindication to disconnect the patient from the mechanical ventilator for RMT treatment or IMT treatment
4. Acute coronary artery disease
5. Thoracic contraindications

Recruitment start date

06/09/2019

Recruitment end date

31/12/2021

Locations

Countries of recruitment

Ireland

Trial participating centre

Connolly Hospital Blanchardstown
Mill Rd Abbotstown
Dublin
D15 X40D
Ireland

Sponsor information

Organisation

Connolly Hospital Blanchardstown

Sponsor details

Mill Rd
Abbotstown
Dublin
D15 X40D
Ireland
+353 1 8213844
therapy.chb@hse.ie

Sponsor type

Hospital/treatment centre

Website

https://www.hse.ie/eng/services/list/3/acutehospitals/hospitals/connolly

Organisation

Anglia Ruskin University

Sponsor details

East Road
Cambridge
CB11PT
United Kingdom
+44 (0)1223 692362
frep-fhems@anglia.ac.uk

Sponsor type

University/education

Website

http://www.anglia.ac.uk/

Funders

Funder type

University/education

Funder name

Anglia Ruskin University

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Study participants will be offered a summary of the study’s results, by post, at the end of the study. The results of this study will be reported via at least one peer-reviewed medical journal. Research findings will also be disseminated at a scientific conference. We will not be naming any organisations (i.e. Hospital) in the report although the principal investigator works at this institution (with is usually named on reports). The hospital ethics committee has given permission to conduct the research.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Raw data will be available for 5 years from when the results are submitted for publication.

Intention to publish date

31/12/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/07/2020: Internal review. 03/07/2020: Trial’s existence confirmed by Connolly Hospital Blanchardstown.