Can performing daily breathing exercises before major surgery reduce the risk of developing lung complications after surgery?

Effectiveness and cost-effectiveness of INSPIRatory musclE training (IMT) for reducing postoperative pulmonary complications (PPC): a sham-controlled randomised controlled trial (RCT): INSPIRE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10644366

Enrollment

2500

Registered

2019-12-20

Start date

2019-12-02

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing major surgery who are at high risk of developing lung complications after surgery Surgery Patients undergoing major surgery who are at high risk of developing lung complications after surgery

Interventions

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. Dur

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, United Kingdom

Contacts

Public ContactDawn Phillips

inspire-study@bristol.ac.uk+44 (0)117 3423564

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026