Comparison of the effectiveness of two different respiratory exercise training methods in prolonged ventilated patients
| ISRCTN | ISRCTN15425727 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15425727 |
- Submission date
- 24/06/2020
- Registration date
- 05/07/2020
- Last edited
- 21/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
Connolly Hospital
Blanchardstown
Physiotherapy Department
Dublin
D15 X40D
Ireland
 ORCID ID |
0000-0002-0728-454X |
|---|---|
| Phone | +353 16465296 |
| kishore.kothapalli@hse.ie |
Study information
| Study design | Interventional randomized parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparing effectiveness REspiratory Muscle Dysfunction Interventions IMT versus RMT study in prolonged ventilated patients |
| Study acronym | REMDI |
| Study objectives | Can respiratory (inspiratory and expiratory) muscle training be feasible and more effective compared to inspiratory muscle training alone in prolonged ventilated patients? |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 18/06/2019 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 06/09/2019 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Abbotstown
Dublin
D15 X40D
Ireland
Sponsor information
Hospital/treatment centre
Mill Rd
Abbotstown
Dublin
D15 X40D
Ireland
| Phone | +353 1 8213844 |
|---|---|
| therapy.chb@hse.ie | |
| Website | https://www.hse.ie/eng/services/list/3/acutehospitals/hospitals/connolly |
"ROR" |
https://ror.org/03h5v7z82 |
University/education
East Road
Cambridge
CB11PT
England
United Kingdom
| Phone | +44 (0)1223 692362 |
|---|---|
| frep-fhems@anglia.ac.uk | |
| Website | http://www.anglia.ac.uk/ |
|
"ROR" |
https://ror.org/0009t4v78 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 21/10/2022 | No | No | ||
| Protocol file | 21/10/2022 | No | No |
Additional files
Editorial Notes
21/10/2022: Protocol and basic results files uploaded.
06/07/2020: Internal review.
03/07/2020: Trial’s existence confirmed by Connolly Hospital Blanchardstown.
