Diaphragmatic Inspiratory Amplitude as a Prognosticator for Postoperative Pulmonary Complications After Cardiac Surgery

NCT06396767 | Recruiting

• 1 other identifier: DIA for POPC
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Determine the utility of diagnostic inspiratory amplitude (DIA) as a prognosticator for postoperative pulmonary complications (POPCs).

  Ultrasonography will be used to measure DIA of patients one day before cardiac surgery and one day after to detect any changes in DIA that occurred and to determine if these changes are associated with POPCs. Occurrence of POPCs will be evaluated by obtaining this data from patient observation.

  One day prior to surgery to one day following surgery

Study Arms (1)

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.

Diagnostic Test: DIA measured via Ultrasonography

Interventions

DIA measured via Ultrasonography DIAGNOSTIC_TEST

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.

DIA measured via Ultrasonography

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients over the age of 18 who present to hospital for elective cardiac surgery.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

RECRUITING

Related Publications (11)

• Moury PH, Cuisinier A, Durand M, Bosson JL, Chavanon O, Payen JF, Jaber S, Albaladejo P. Diaphragm thickening in cardiac surgery: a perioperative prospective ultrasound study. Ann Intensive Care. 2019 Apr 24;9(1):50. doi: 10.1186/s13613-019-0521-z.

  PMID: 31016412 BACKGROUND

• Cavayas YA, Eljaiek R, Rodrigue E, Lamarche Y, Girard M, Wang HT, Levesque S, Denault AY. Preoperative Diaphragm Function Is Associated With Postoperative Pulmonary Complications After Cardiac Surgery. Crit Care Med. 2019 Dec;47(12):e966-e974. doi: 10.1097/CCM.0000000000004027.

  PMID: 31609771 BACKGROUND

• Naveed A, Azam H, Murtaza HG, Ahmad RA, Baig MAR. Incidence and risk factors of Pulmonary Complications after Cardiopulmonary bypass. Pak J Med Sci. 2017 Jul-Aug;33(4):993-996. doi: 10.12669/pjms.334.12846.

  PMID: 29067080 BACKGROUND

• Vanamail PV, Balakrishnan K, Prahlad S, Chockalingam P, Dash R, Soundararajan DK. Ultrasonographic Assessment of Diaphragmatic Inspiratory Amplitude and Its Association with Postoperative Pulmonary Complications in Upper Abdominal Surgery: A Prospective, Longitudinal, Observational Study. Indian J Crit Care Med. 2021 Sep;25(9):1031-1039. doi: 10.5005/jp-journals-10071-23962.

  PMID: 34963722 BACKGROUND

• Pasero D, Costamagna A, Marchisio A, Pivetta E, Giunta M, Fanelli V, Brazzi L. Diaphragmatic dysfunction following cardiac surgery: Observational study. Eur J Anaesthesiol. 2019 Aug;36(8):612-613. doi: 10.1097/EJA.0000000000000969. No abstract available.

  PMID: 31274546 BACKGROUND

• Bruni A, Garofalo E, Pasin L, Serraino GF, Cammarota G, Longhini F, Landoni G, Lembo R, Mastroroberto P, Navalesi P; MaGIC (Magna Graecia Intensive care and Cardiac surgery) Group. Diaphragmatic Dysfunction After Elective Cardiac Surgery: A Prospective Observational Study. J Cardiothorac Vasc Anesth. 2020 Dec;34(12):3336-3344. doi: 10.1053/j.jvca.2020.06.038. Epub 2020 Jun 17.

  PMID: 32653270 BACKGROUND

• Laghlam D, Naudin C, Srour A, Monsonego R, Malvy J, Rahoual G, Squara P, Nguyen LS, Estagnasie P. Persistent diaphragm dysfunction after cardiac surgery is associated with adverse respiratory outcomes: a prospective observational ultrasound study. Can J Anaesth. 2023 Feb;70(2):228-236. doi: 10.1007/s12630-022-02360-8. Epub 2022 Dec 13.

  PMID: 36513852 BACKGROUND

• Lerolle N, Guerot E, Dimassi S, Zegdi R, Faisy C, Fagon JY, Diehl JL. Ultrasonographic diagnostic criterion for severe diaphragmatic dysfunction after cardiac surgery. Chest. 2009 Feb;135(2):401-407. doi: 10.1378/chest.08-1531. Epub 2008 Aug 27.

  PMID: 18753469 BACKGROUND

• Tralhao A, Cavaleiro P, Arrigo M, Lopes JP, Lebrun M, Rivas-Lasarte M, Le Pimpec-Barthes F, Latremouille C, Achouh P, Pirracchio R, Cholley B. Early changes in diaphragmatic function evaluated using ultrasound in cardiac surgery patients: a cohort study. J Clin Monit Comput. 2020 Jun;34(3):559-566. doi: 10.1007/s10877-019-00350-8. Epub 2019 Jul 5.

  PMID: 31278543 BACKGROUND

• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. 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. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

  PMID: 25058504 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

Study Officials

• Raffael Zamper, MD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raffael Zamper, MD

CONTACT

51966858500; raffael.pereiracezarzamper@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Assistant Professor

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 2, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)