Can performing daily breathing exercises before major surgery reduce the risk of developing lung complications after surgery?
| ISRCTN | ISRCTN10644366 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10644366 |
| IRAS number | 250345 |
| Secondary identifying numbers | 6296, HTA 16/140/07, CPMS 39337, IRAS 250345 |
- Submission date
- 25/11/2019
- Registration date
- 20/12/2019
- Last edited
- 31/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Major operations in the stomach or chest provide life-saving operations for people with cancer or a heart condition. As with all major surgery, there is a chance of developing complications after the operation. The Inspire study is concerned with lung complications, including pneumonia. Lung complications after surgery are common, affecting on average one in ten patients, although it depends on the current health of the person and the type of surgery they are having. Lung complications have a long term effect, and can reduce life expectancy for up to ten years after the operation. Poor health due to lung complications also increases healthcare costs. Consequently, trying to prevent lung complications is important for both patients and the NHS.
The study aims to investigate whether breathing training reduces lung complications in patients who, because of their health or the operation they are having, have a higher than average risk of developing lung complications after surgery. Some studies have shown that training for as little as two weeks before a major operation halves the risk of lung complications. The benefits of this training, however, remain uncertain as previous studies recruited too few patients and many were not done well.
Who can participate?
Adult patients having operations in the chest or stomach under general anaesthesia.
What does the study involve?
The Inspire study is investigating whether a series of daily breathing exercises that aim to improve the strength and endurance of the muscles in the chest can help to reduce the chances of getting a lung complication after surgery. The exercises involve using a hand-held device held up to the mouth, through which the patient will breathe in and out. Training takes approximately 15 minutes twice a day and can be performed at home whilst sitting down.
To try to make sure the groups are the same to start with, each patient is put into a group randomly. Each person taking part will have an equal chance of being in either group. If a patient takes part in the research neither they, nor the surgeon, nor the research team will be able to choose which breathing technique they are given.
Groups 1 & 2: Breathing training with the hand-held device with resistance/difficulty differences: Patients will be taught how to use the device and perform the exercises and instructed to do the exercises twice a day (30 breaths each time, which will take approximately 15 minutes) for a
minimum of 2 weeks. If the patients have a longer wait for surgery or their surgery date is rescheduled then they can continue doing the exercises until the day before their operation.
Group 3: Breathing exercises without the hand-held device: Patients will be given an instruction leaflet with a series of deep breathing exercises but will otherwise have no additional breathing training before surgery.
What are the possible benefits and risks of participating?
The researchers cannot promise that the study will help participants, but they anticipate that participants who perform breathing exercises before surgery will have fewer lung complications and recover from surgery more quickly. The results from this study may help improve the management of some complications that could develop after surgery, for other people having operations in the future.
There are no known risks associated with performing breathing exercises. However, if participants have problems operating the breathing device or experience untoward events the local research team will provide contact details on joining the study.
There should also be no risks associated with participating in the information study, as this only involves audio-recording conversations participants have with hospital staff and researchers. Most people find these conversations helpful but some can find it upsetting. If this happens, participants will be able to stop the appointment or interview at any time, without giving a reason.
Where is the study run from?
Bristol Trials Centre at the University of Bristol (UK)
When is the study starting and how long is it expected to run for?
November 2019 to July 2023
Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme (UK)
Who is the main contact?
1. Dawn Phillips (public)
inspire-study@bristol.ac.uk
2. Dr Maria Pufulete
maria.pufulete@bristol.ac.uk
Contact information
Public
Bristol Trials Unit (CTEU)
University of Bristol
Zone A719 Queens Building
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
 ORCID ID |
0000-0002-1322-472X |
|---|---|
| Phone | +44 (0)117 3423564 |
| inspire-study@bristol.ac.uk |
Scientific
Bristol Trials Unit (CTEU)
University of Bristol
Zone A719 Queens Building
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
| ORCID ID |
0000-0002-1775-1949 |
|---|---|
| Phone | +44 (0)117 342 4195 |
| maria.pufulete@bristol.ac.uk |
Study information
| Study design | Pragmatic parallel three-group multi-center interventional randomized controlled trial (with an internal pilot) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness and cost-effectiveness of INSPIRatory musclE training (IMT) for reducing postoperative pulmonary complications (PPC): a sham-controlled randomised controlled trial (RCT): INSPIRE |
| Study acronym | INSPIRE |
| Study objectives | Inspiratory muscle training (IMT) performed twice per day for a minimum of 2 weeks before an operation reduces the risk of lung complications in patients at high risk of having lung complications. |
| Ethics approval(s) | Approved 16/05/2019, London - Bloomsbury Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH; +44 (0)207 104 8063; nrescommittee.london-bloomsbury@nhs.net), ref: 19/LO/0546 |
| Health condition(s) or problem(s) studied | Patients undergoing major surgery who are at high risk of developing lung complications after surgery |
| Intervention | Current intervention as of 05/10/2020: INSPIRE is a pragmatic parallel, 3 group multi-center RCT (with an internal pilot) with high-resistance IMT, low-resistance IMT and usual care interventions. During the internal pilot we will also conduct a study within a trial (SWAT). The pilot study will check whether participants need more than one session of training to be able to use the breathing device correctly and whether a device with a manual or automatic setting improves breathing function. If it is found that the additional virtual training session and/or the manual or automatic device improves device use and/or breathing function we may incorporate these into Phase 2 of the study. The main study consists of patients being recruited in a 2:1:1 ratio whilst the SWAT consists of a further randomisation in a 2x2 factorial design to one of four group allocations. Patients will receive appropriate training and advice regarding breathing exercises and may be asked to train for a minimum of 2 weeks before their planned operation. _____ Previous intervention: INSPIRE is a pragmatic parallel, 3 group multi-center RCT (with an internal pilot) with high resistance IMT, low resistance IMT and usual care interventions. During the internal pilot we will also conduct a study within a trial (SWAT). The pilot study will check whether participants need more than one session of training to be able to use the breathing device correctly. There will be two groups as follows: Group A: Extra one-off hospital visit one week after being randomised to Group 1 to receive further training on using the breathing device. Group B: No additional hospital visits or training. Results will be analysed at the end of the pilot study, and if it is found that the additional training improves device use we may include the extra training in the larger study. The main study consists of patients being recruited in a 2:1:1 ratio into one of the following three groups: 1. High resistance inspiratory muscle training (IMT) training at 50% of their maximal inspiratory pressure (MIP) 2. Low resistance IMT (control) training at 10% of their MIP 3. Usual care arm (patients will be given a breathing exercise leaflet) The random allocation will be stratified by hospital site and specialty. During Phase 1 of the study patients randomised to the high resistance IMT arm will be included in a study within a trial (SWAT) and will be further randomised in a 2x2 factorial design to one of the following four groups: 1. Automatic load adjustment and an additional hospital visit 2. Automatic load adjustment and no additional hospital visit 3. Manual load adjustment and an additional hospital visit 4. Manual load adjustment and no additional hospital visit Patients will receive appropriate training on how to use the device and on how to perform breathing exercises and will be asked to train for a minimum of 2 weeks but no longer than 8 weeks before their planned operation. |
| Intervention type | Behavioural |
| Primary outcome measure | Incidence of any post-pulmonary complication (PPC) occurring in-hospital (before discharge) or hospital readmission for a PPC within 30 days from surgery in each of the three care groups. We will use the composite outcome proposed by the European Society of Anaesthesiology and the European Society of Intensive Care Medicine as a consensus definition for PPC. This includes respiratory failure, respiratory infection, atelectasis, pleural effusion, pneumothorax, aspiration pneumonitis and bronchospasm; there are specified diagnostic criteria for each component. |
| Secondary outcome measures | Measured using patient notes unless stated otherwise: 1. Incidence of each of the seven individual components of the composite primary outcome (defined using the European Society of Anaesthesiology and the European Society of Intensive Care Medicine) during the study period: 1.1. Respiratory infection (patient notes & chest x ray) 1.2. Respiratory failure 1.3. Pleural effusion (patient notes & chest x ray) 1.4. Atelectasis (patient notes & chest x ray/chest ct) 1.5. Pneumothorax (patient notes & chest x ray) 1.6. Bronchospasm 1.7. Aspiration pneumonitis (patient notes & chest x ray) 2. The requirement for postoperative ventilation (invasive ventilation; non-invasive ventilation ( including continuous positive airway pressure (CPAP) and/or pressure support (BIPAP)); or Optiflow (high flow nasal oxygen therapy)). For non-invasive ventilation and high flow nasal oxygen therapy the researchers will distinguish prophylactic use from use to treat a pulmonary complication 3. Length of ICU stay 4. Length of hospital stay (including readmissions) 5. Antibiotic prescription given during hospital stay 6. Bronchodilator prescription given during hospital stay 7. Quality of life measured using HRQoL questionnaires at baseline and day of surgery, 3 months & 6 months. A combination of the following questionnaires will be issued across the 4 timepoints: EQ-5D-DL; SF-12; Connor Davidson Resilience; Duke Activity Status Index; Hospital Anxiety And Depression Scale; Self-efficacy; Surgical Regret 8. Maximal inspiratory pressure (MIP) measured using POWERbreathe device that calculates residual volume at baseline and randomisation, additional training visit (for those patients randomised to an extra visit) and day of surgery 9. Spirometry (forced expiratory volume, FEV1 and forced vital capacity, FVC) measured using a spirometer at baseline, randomisation and day of surgery 10. Training load measured using POWERbreathe device and patient diary at baseline and day of surgery 11. Mortality 12. Resource use collected from patient notes & patient questionnaires at 3 and 6 months 13. Other complications of surgery documented using the Clavien-Dindo classification and the Comprehensive Classification Index |
| Overall study start date | 01/10/2018 |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2,500 |
| Total final enrolment | 337 |
| Key inclusion criteria | 1. Aged ≥18 years 2. Elective major cardiac, thoracic and abdominal surgery (oesophageal, gastric, hepatobiliary, colorectal, gynaecological, urological, or open aortic aneurysm repair) under general anaesthesia, including both open and laparoscopic surgery 3. ARISCAT score ≥26 4. At least 14 days until planned operation date 5. Able to give informed consent |
| Key exclusion criteria | 1. Emergency surgery 2. Unable to participate in the intervention (e.g. have cognitive impairment) 3. Lack capacity to consent 4. Recent cardiac, thoracic or open abdominal surgery (in previous 2 months) 5. Prisoners 6. Patients with a history of spontaneous pneumothorax (if a patient has had a traumatic pneumothorax and are fully recovered, then they can be included) 7. Eardrum perforation within 6 weeks 8. Phrenic nerve palsy |
| Date of first enrolment | 02/12/2019 |
| Date of final enrolment | 30/10/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Southampton
SO16 6YD
United Kingdom
Guildford
GU2 7XX
United Kingdom
Glossop Rd
Sheffield
S10 2JF
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Chelsea
London
SW3 6JJ
United Kingdom
Castle Rd
Cottingham
Hull
HU16 5JQ
United Kingdom
Lister Road
Nottingham
NG7 2FT
United Kingdom
Bristol
BS1 3NU
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Innovation
Bristol Royal Infirmary
Upper Maudlin Street
http://www.uhbristol.nhs.uk/research-innovation/
Bristol
BS2 8HW
England
United Kingdom
| Phone | +44 (0)117 34 20233 |
|---|---|
| research@uhbw.nhs.uk | |
| Website | https://www.uhbw.nhs.uk |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | A full report will be written for the NIHR HTA and the findings will be presented at national and international conferences, and the results published in peer-reviewed journals. Several aspects of the study (e.g. the inclusion of both a low resistance IMT and usual care arms will allow the researchers to assess the efficacy of blinding such an intervention) will inform RCTs of lifestyle interventions in general and these will be reported at methodology meetings. The researchers will also link with the British Heart Foundation, Cancer Research UK, the Royal College of Anaesthetists and the James Lind Alliance Priority Setting Partnership for Anaesthesia and Perioperative Care, the UK Perioperative Medicine Clinical Trials Network, the National Institute of Academic Anaesthesia (NIAA) and NIAA Health Services Research Centre, the European Society of Anaesthesiology, and other relevant clinical studies groups (CSGs) (e.g. lung cancer CSG). They will use social networking media to disseminate and publicise the study via a website or social media streams. They will also work with PPI groups to identify how they can best publicise their findings. Expected outputs include publication of the protocol and the results of the RCT informing clinicians and patients on the efficacy of IMT for preventing postoperative complications. The study will also provide information on the feasibility of delivering a lifestyle intervention in a pragmatic fashion to patients in the NHS setting. The health economic evaluation will provide evidence on the cost effectiveness of IMT and whether it presents value for money for the NHS. The results of the study will inform national and international guidelines on optimising the perioperative care pathway. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v3.0 | 13/08/2020 | 05/10/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN10644366_Protocol_v3.0_13Aug2020.pdf
- Uploaded 05/10/2020
Editorial Notes
31/05/2024: The intention to publish date was changed from 01/12/2023 to 30/09/2024.
10/07/2023: The following changes were made to the trial record:
1. The overall end date was changed from 30/03/2022 to 31/07/2023.
2. The intention to publish date was changed from 01/03/2023 to 01/12/2023.
3. The plain English summary was updated to reflect these changes.
4. The total final enrolment was added.
03/09/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2021 to 30/10/2021.
2. The overall trial end date has been changed from 30/09/2021 to 30/03/2022.
3. The trial website has been added.
4. The trial participating centre "University Hospitals Bristol and Weston NHS Foundation Trust" has been added.
5. The sponsor details have been updated.
6. The plain English summary has been updated to reflect the changes above.
05/10/2020: The following changes have been made:
1. Recruitment has resumed.
2. Uploaded protocol ISRCTN10644366_Protocol_v3.0_13Aug2020 (not peer-reviewed).
3. The intervention has been changed.
4. Northern General Hospital has been removed from the trial participating centres.
5. The plain English summary has been updated to reflect the change in intervention.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused. The following changes have been made:
1. The IRAS number has been added.
2. The trial participating centres "Northern General Hospital", "Castle Hill Hospital", "Nottingham University Hospitals" and "Royal Marsden Hospital" have been added.
13/01/2020: Added CPMS number.
20/12/2019: Trial's existence confirmed by the NIHR.
