Using Ultrasound to Measure Diaphragm Movement to Predict Lung Problems After Heart Surgery
Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2024-10-09
130
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the potential of Diaphragmatic Inspiratory Amplitude DIA measured by ultrasound as a predictor for Post-Operative Pulmonary Complications POPCs in patients undergoing elective cardiac surgery. POPCs, which include pneumonia, atelectasis, and prolonged mechanical ventilation, pose significant risks such as increased morbidity, mortality, and healthcare costs. Diaphragmatic dysfunction, occurring in up to 20% of cardiac surgery patients, is linked to these respiratory complications but remains under-evaluated in this context.
The study involves measuring DIA using ultrasound before surgery and on the first day after surgery on both sides of the diaphragm during quiet and deep breathing. Eight measurements per patient are taken to assess diaphragmatic movement. Standard cardiac surgery care, including anesthesia and monitoring protocols, continues as usual. Ultrasound measurements are conducted with specific probes to ensure consistent assessment, and postoperative care follows institutional protocols without influence from DIA results.
Participants will be monitored for POPCs up to five days after surgery or until hospital discharge. Data collected include diaphragmatic movement measurements, clinical assessments, and diagnoses of pulmonary complications based on established guidelines. Measurements are taken when patients are comfortable and off mechanical ventilation or non-invasive ventilation. The primary outcome is to determine if DIA can predict POPCs, with outcomes reviewed by investigators unaware of DIA results to maintain impartiality.
CONDITIONS
Brief Title
Diaphragmatic Inspiratory Amplitude as a Prognosticator for Postoperative Pulmonary Complications After Cardiac Surgery
Research Team
R
Raffael Zamper, MD
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Who Can Participate
Age: 19Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
All patients aged over 18 years undergoing elective cardiac surgery
You will not qualify if you...
Previous cardiac surgery (redo surgery)
Pre-existing central nervous system diseases such as Parkinson's disease, brain injury, or psychiatric disorders
Emergency cardiac surgery
Surgeries performed via thoracotomy approach
Pre-surgery ICU stay, use of non-invasive ventilation, or mechanical ventilation
Hemodynamic instability requiring vasopressors or intra-aortic balloon pump before surgery
Age under 18 years
Elevated hemidiaphragm on chest X-ray before surgery
Pre-existing neuromuscular disorders like myasthenia gravis
Planned heart transplantation
Use of mechanical circulatory support before surgery
Inability to provide consent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo preoperative ultrasonographic measurements of their diaphragm function one day before elective cardiac surgery to establish baseline diaphragmatic inspiratory amplitude (DIA) values.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Surgery day plus immediate recovery period
Participants undergo elective cardiac surgery followed by immediate postoperative care in the Cardiac Surgical Recovery Unit (CSRU) as per standard institutional protocols.
1 hospital stay including surgery and recovery
Diagnostic Evaluation
Duration - 1 day
Participants have postoperative ultrasonographic measurements of diaphragmatic inspiratory amplitude (DIA) on postoperative day 1 in the CSRU to assess diaphragm function after surgery.
1 visit (in-person) in hospital
Long-term Monitoring
Duration - Up to 5 days or until hospital discharge
Participants are observed for postoperative pulmonary complications (POPCs) including pneumonia, atelectasis, and prolonged mechanical ventilation up to postoperative day 5 or hospital discharge, whichever occurs first.
Clinical monitoring during hospital stay
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Ultrasonographic Assessment of Diaphragmatic Inspiratory Amplitude and Its Association with Postoperative Pulmonary Complications in Upper Abdominal Surgery: A Prospective, Longitudinal, Observational Study.
Prasanna V Vanamail, Kalpana Balakrishnan, Sarojini Prahlad...
Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures.