Recruiting

Observational Study

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT06396767

Conditions

Postoperative Pulmonary Complications

Cardiac Surgery

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

DIA measured via Ultrasonography

Study Details

Brief summary:

Cardiac surgery is a critical intervention for a variety of cardiovascular conditions, yet it can frequently results in a spectrum of postoperative complications. Amongst various morbidities, Post-Operative Pulmonary Complications (POPCs) represent a significant clinical challenge leading to adverse outcomes like increased morbidity, mortality, and raised healthcare expenditures. The diaphragm, as the principal respiratory muscle, plays a pivotal role in maintaining pulmonary function. Diaphragmatic dysfunction (DD) in the perioperative period of Cardiac surgery has an incidence of up to 20%. Understanding the impact of DD on postoperative pulmonary function is imperative for optimizing patient care and clinical outcomes. Its occurrence has been linked to a spectrum of respiratory complications, ranging from pneumonia to difficulty in weaning from mechanical ventilation. In recent years, the advent of point-of-care ultrasonogram (POCUS) has emerged as a promising modality for real-time monitoring of DD. It offers a more accessible and feasible approach compared to traditional methods, providing immediate feedback on diaphragmatic movement, and facilitates timely intervention. Ultrasound has been used to assess Diaphragmatic Inspiratory Amplitude (DIA) (the expansion of the diaphragm when breathing). DIA has been shown to decrease in the post-operative period after cardiac surgery, which has been well-correlated with the occurrence of POPCs, however, its predictive value has not yet been studied in a cohort of cardiac surgical patients. Hence, we aim to address this gap by exploring the utility of DIA measured by ultrasonogram as a predictive tool in anticipating the occurrence of POPCs. We hypothesize that DIA can predict the occurrence of POPC in cardiac surgical patients. We will recruit 130 patients at University Hospital, London Health Science Centre, to this prospective, observational study.

Conditions

Postoperative Pulmonary Complications

Cardiac Surgery

Study ID

NCT06396767

Start date

Jun 1, 2024

Status verified date

Oct, 2024

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients aged>18 years and undergoing elective cardiac surgery.

Exclusion Criteria:

1. . Redo Cardiac surgery.
2. . Pre-existing CNS disease (like Parkinson's disease) or Brain injury or Psychiatric disorder
3. . Emergency cardiac surgery
4. . Surgeries done via Thoracotomy approach.
5. . Pre-surgery ICU stay/ on NIV/ on mechanical ventilation.
6. . Pre-surgery Hemodynamic instability requiring vasopressors/IABP institution.
7. . Age<18
8. . Elevated hemidiaphragm before surgery on chest x ray
9. . Pre-existing neuromuscular disorders (like myasthenia gravis etc.)
10. . Patients planned for heart transplantation.
11. . Patients on mechanical circulatory support preoperatively (intra-aortic balloon pump, extracorporeal membrane oxygenation, or ventricular assist device).
12. . Inability to give consent.

Study Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Arms

DIA measured via Ultrasonography

Ultrasonographic measurements will be done preoperatively a day before surgery (T0) and on Postoperative day 1(T1) in Cardiac Surgery Recovery Unit (CSRU). Measurements will be done on both right and left sides during Quiet (Q) and Deep (D) breathing in semi- recumbent posture (30-450 recline of the bed).

Three measurements will be taken during both quiet and deep breathing and an average value will be derived (Qavg and Davg). this will be done for both right and left hemidiaphragms (both pre-surgery and post-surgery). So, for each patient a total of 8 diaphragmatic measurements will be obtained (4 in the pre-surgery period and another 4 in post-surgery period). Measurement technique and definition of Diaphragmatic Inspiratory Amplitude:

All examinations will be performed by Sonosite SII ultrasound machine (FUJIFILM Sonosite Inc, Bothell, WA, USA) using a 3.5- to5 MHz phased array probe or a 3-12 MHz linear probe.

Interventions

DIA measured via Ultrasonography

Ultrasound will be used to measure Diaphragmatic Inspiratory Amplitude (DIA) of patients before and after elective cardiac surgery to determine if there is a correlation between changes in DIA and postoperative pulmonary complications.

Primary outcome measure

  • Determine the utility of diagnostic inspiratory amplitude (DIA) as a prognosticator for postoperative pulmonary complications (POPCs). [ Time Frame: One day prior to surgery to one day following surgery ]

Central Contacts and Locations

Central contacts

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Oct 9, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-10-09.