Clinical Trials Logo

Clinical Trial Summary

The Lund de-airing technique is employed for cardiac de-airing in open left heart surgery. It consists of two main elements namely, opening of both pleura after the patient is on CPB (cardiopulmonary bypass)and disconnection of the ventilator before opening the left heart to ensure bilateral pulmonary collapse and a staged filling of the heart at termination of the CPB. The aim of this study is to analyze in a randomized manner two groups of patients to establish if one or both components are of primary importance for the effectiveness of the de-airing technique.


Clinical Trial Description

Patients planned for open left heart surgery, mainly aortic valve replacement, will be included in the study. Patients with aortic valve replacement and concomitant coronary artery bypass with vein grafts only can also be included.

Exclusion criteria are; significant chronic obstructive pulmonary disease/emphysema, significant (>50%)carotid artery disease, need of concomitant internal mammary harvesting, prior cardiac or pulmonary surgery, pulmonary adhesions preventing pulmonary collapse, previous radiation to the chest and prior severe chest trauma. Intraoperative exclusion criteria are; failure to obtain adequate bilateral Trans-cranial Echo-Doppler signals from the medial cerebral arteries, finding of adherent pleurae and accidental opening of the pleurae.

Twenty patients will be randomized to two groups:

Group I: Intact pleura bilaterally, disconnection of the ventilator during cardiopulmonary bypass (CPB), followed by staged filling of the heart.

Group II: Open pleura bilaterally, disconnection of the ventilator during cardiopulmonary bypass to ensure bilateral pulmonary collapse followed by conventional filling of the heart.

Data will be compared to a third historical control group, consisting of ten patients with open pleurae with the ventilator disconnected followed by staged filling of the heart.

Primary outcomes:

- Duration of the de-airing procedure from the release of the aortic cross clamp to finished de-airing.

- Air microemboli to the brain registered on-line as gaseous microembolic signals on Trans-cranial Echo-Doppler (TCD). The sum of signals from the right and left middle cerebral artery are registered during the following time periods; from the release of the aortic cross clamp to start of cardiac ejection, from cardiac ejection to finished de-airing, and during ten minutes after finished de-airing.

- Magnitude of residual air emboli in the heart after finished de-airing as monitored by Trans-esophageal Echocardiography (TEE) with a Three-chamber view. The severity of residual air is classified in four grades after the appearance of visible air on TEE in left atrium (LA), left ventricle (LV) and aortic root (AO)as follows; Grade 0: no residual air, grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle, grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected in all three anatomic areas during one cardiac cycle. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Complication of Surgical Procedure

NCT number NCT01757704
Study type Interventional
Source Lund University
Contact
Status Completed
Phase N/A
Start date September 2012
Completion date January 2014

See also
  Status Clinical Trial Phase
Recruiting NCT02789579 - The Preventive Infection Role of One Week Antibiotics Before Minimally Invasive Upper Tract Lithotomy Early Phase 1
Withdrawn NCT02374294 - TCOT Effectiveness in Preventing Wound Infections in Perineal Resections Phase 2
Completed NCT02252562 - Hand Hygiene and Hospital Acquired Infections N/A
Recruiting NCT05005117 - Laparoscopic Approach for Emergency Colon Resection N/A
Enrolling by invitation NCT03234543 - Remote Ischemic Conditioning in Abdominal Surgery N/A
Completed NCT04849702 - Comparison of the Clavien-Dindo and Comprehensive Complication Index
Completed NCT04120324 - Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty
Recruiting NCT05761821 - Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis
Active, not recruiting NCT05795127 - Risk for Reoperation After First MTP Joint Arthrodesis
Completed NCT04550156 - Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections N/A
Recruiting NCT05194943 - Trends and Safety in Revisional Bariatric Surgery in Italy
Not yet recruiting NCT03313986 - Outcomes of Surgical Correction of Penile Curvature in Adult N/A
Enrolling by invitation NCT04456530 - Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study Phase 2/Phase 3
Completed NCT03125798 - Comparison of LigaSure to Conventional Electrocoagulation in Video-assisted Thoracoscopic Surgery Lobectomy N/A
Completed NCT04226482 - Review of Efficacy of Used ultraSonic Energy Device N/A
Completed NCT01739374 - Efficacy and Safety of Reduced Pelvic Floor Mesh Implants Phase 2/Phase 3
Completed NCT01346709 - Prospective Evaluation of a RIsk Score for Postoperative Pulmonary COmPlications in Europe
Recruiting NCT02212054 - A Trial on Treatments of Hirschsprung Allied Disease N/A
Completed NCT04352699 - Outcomes of Urological Surgery During Periods of Social COVID-19 Containemnt: is it Reasonable to Limit Access to Surgical Care for All?
Completed NCT04683666 - Cardiovascular Risk Factors of Medical and Septic Complications After Laparoscopic Bariatric Surgery