Ventilation During Cardiopulmonary Bypass (CPB) for Cardiac Surgery

NCT02070445 | Withdrawn

• 1 other identifier: 13-859
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

During most types of heart surgery cardiopulmonary bypass (CPB) is used. CPB enables blood to be directed away from the heart and the lungs and pumped through the body while the heart is not beating. Surgery on the heart easier when it is not beating and bloodless area. Generally during CPB the lungs do not need to be ventilated, as no blood is flowing through the lungs and the body received oxygen from a machine (oxygenator) attached to the CPB pump. In this study we are investigating the difference in lung collapse after heart surgery in patient who did have their lungs ventilated during CPB, compared to patients who did not have their lungs ventilated during CPB. We will use lung ultrasound scans to determine the degree of lung collapse at various time periods before and after the heart surgery. We will also investigate if ventilation during CPB will affect: a.) the rate of lung infection or pneumonia after the operation b.) the time it takes for a patient to have the breathing tube removed in the intensive care unit after the operation c.) the time for a patient to be discharged home from the hospital d.) the concentration of oxygen in the blood after the operation.

Conditions

Pulmonary Atelectasis

Keywords

CABG; pilot; ultrasound; perioperative; low tidal volume ventilation

Outcome Measures

Primary Outcomes (1)

• Time to complete study in operating room and ICU

  To assess feasibility of LUS investigation in pre-operative and post-operative patients (time required to complete study in operating room and ICU, practicality of performing LUS in a busy environment). The LUS investigations are reported to be a fast and reliable investigation. However, few data are available about its use in a perioperative setting.

  3 months

Secondary Outcomes (2)

• Assess the evolution of LUS

  3 months

• Determine sample size for future Randomized Control Trial

  3 months

Study Arms (1)

Patients undergoing CABG

Patients will have no ventilation during CABG. There will be non-invasive assessments of the lung using ultrasound at different times during the perioperative period.The first assessment will be conducted before anesthesia induction (i.e. patients will be awake). A second assessment will be conducted after anesthesiology induction, but before the beginning of surgery. A third assessment will be conducted at the end of the surgery in the operating room. And two subsequent assessments will be conducted in ICU before and after extubation.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Same Day Surgery Clinic

You may qualify if:

• Adult elective coronary artery bypass surgery requiring CPB

You may not qualify if:

• Cardiac surgery without CPB
• Complex cardiac surgery (valve repairs, combined bypass and valve repairs etc.)
• Emergency cardiac surgery
• Fibrotic lung disease
• Previous lung volume reduction surgery (CXR will be assessed pre-operatively)
• Massive blood product transfusion intra- and/or post-operatively will exclude patient
• Patients enrolled in other studies eg. SIRS study (steroid use)

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (1)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (3)

• Taggart DP, el-Fiky M, Carter R, Bowman A, Wheatley DJ. Respiratory dysfunction after uncomplicated cardiopulmonary bypass. Ann Thorac Surg. 1993 Nov;56(5):1123-8. doi: 10.1016/0003-4975(95)90029-2.

  PMID: 8239811 BACKGROUND

• Apostolakis EE, Koletsis EN, Baikoussis NG, Siminelakis SN, Papadopoulos GS. Strategies to prevent intraoperative lung injury during cardiopulmonary bypass. J Cardiothorac Surg. 2010 Jan 11;5:1. doi: 10.1186/1749-8090-5-1.

  PMID: 20064238 BACKGROUND

• Asimakopoulos G, Smith PL, Ratnatunga CP, Taylor KM. Lung injury and acute respiratory distress syndrome after cardiopulmonary bypass. Ann Thorac Surg. 1999 Sep;68(3):1107-15. doi: 10.1016/s0003-4975(99)00781-x.

  PMID: 10510030 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Summer Syed, MD

  McMaster University and Hamilton Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 8, 2019

Record last verified: 2019-03

Locations

CA (1)