Feasibility, acceptability and change in inspiratory muscle strength in patients performing supervised breathing strengthening exercises using an inspiratory muscle trainer (IMT) device while waiting in hospital to have urgent cardiac surgery.

Not Applicable

• Conditions: Cardiothoracic Surgery; Surgery - Other surgery; Cardiovascular - Other cardiovascular diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12622001151729
• Lead Sponsor: The Prince Charles Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-23
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Adult patients who can provide written informed consent and are admitted to TPCH for urgent cardiac surgery with cardiopulmonary bypass (for this study defined as patients admitted to hospital following the diagnosis of their heart condition and considered not safe to be discharged home before their surgery). Participants will be included in this study if they are determined to be at higher risk of developing PPCs as per current evidence. This would include one or more of the following:
•Current or recent smoker – defined as any amount of smoking history within 1 year of study recruitment
•Diagnosed COPD – defined by medical documentation of COPD, and/or respiratory function tests, and/or current or long-term use of respiratory medications
•Age greater than or equal to 70 years
•BMI greater than or equal to 30 kg/m2
•Clinical Frailty Scale greater than or equal to 4
•Diabetes Mellitus on pharmacological treatment

Exclusion Criteria

Exclusion criteria
•<18 years of age
•Unable to provide informed consent and/or unable to participate due to cognitive issues, intellectual disability or neurological impairment
•Emergency/salvage surgery or insufficient time to provide effective intervention (cardiac surgery within 48 hours of diagnosis, admission or recruitment)
•Patients discharged home prior to surgery
•Contraindications/precautions to IMT:
oLarge emphysematous bullae
oRecent or current pneumothorax
oRecent lung anastomosis – within past 8 weeks
oSevere osteoporosis with high risk of rib fractures
oCurrent fractured or flail ribs
oAcute/unstable angina
oKnown perforated eardrum
oHaemodynamic instability -new significant arrhythmias, alteration in BP requiring an alteration in vasoactive medication, Systolic BP > 180mmHg or <85, HR >130 or <50, and/or fluctuations in BP or HR causing symptoms, Acute/decompensated cardiac failure or severe/decompensated valvular disorders as determined by medical staff
oSignificant pain affecting breathing capacity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility is a composite primary outcome - defined as 50 percent or more planned sessions completed, and 4 or more sessions completed - via recording on the study assessment form[Cumulative data will be assessed at the conclusion of the study];Acceptability of IMT - via an IMT Acceptability Questionnaire. This questionnaire has been designed for this study[Immediately prior to participants surgery];Consent and Recruitment rate including reasons for lack of consent - via patient interview and recording on study assessment form[Cumulative data will be assessed at the conclusion of the study]