Actively Recruiting

Age: 19Years - 99Years
All Genders
ID06396767

Diaphragmatic Inspiratory Amplitude Measured by Ultrasonography as a Predictor for Postoperative Pulmonary Complications After Cardiac Surgery: A Prospective Observational Study

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

On this page

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

Who Can Participate

Age: 19Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients aged over 18 years undergoing elective cardiac surgery
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Trial Site Locations

Total: 1 location

1

London Health Sciences Centre

London, Ontario, Canada

Actively Recruiting

Loading map...

Research Team

R

Raffael Zamper, MD

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

Similar Trials

Preoperative Risk Assessment and Shared Decision-Making in P...

Frail Elderly Persons

Actively Recruiting

1 location

Affecting Factors the Incidence of Chronic Pain After Sterno...

Cardiac Surgery

Actively Recruiting

2 locations

Angiopoietin Dysregulation to Predict Adverse Outcomes in Ca...

Cardiac Surgery

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Preoperative Diaphragm Function Is Associated With Postoperative Pulmonary Complications After Cardiac Surgery.

Yiorgos Alexandros Cavayas, Roberto Eljaiek, Élise Rodrigue...

https://pubmed.ncbi.nlm.nih.gov/31609771

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...

https://pubmed.ncbi.nlm.nih.gov/34963722

Persistent diaphragm dysfunction after cardiac surgery is associated with adverse respiratory outcomes: a prospective observational ultrasound study.

Driss Laghlam, Cecile Naudin, Alexandre Srour...

https://pubmed.ncbi.nlm.nih.gov/36513852

Early changes in diaphragmatic function evaluated using ultrasound in cardiac surgery patients: a cohort study.

António Tralhão, Pedro Cavaleiro, Mattia Arrigo...

https://pubmed.ncbi.nlm.nih.gov/31278543

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.

Ib Jammer, Nadine Wickboldt, Michael Sander...

https://pubmed.ncbi.nlm.nih.gov/25058504