Clinical trial NCT05094843: The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery
Official title: The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Surgery
Arrhythmia
Myocardial Ischemia
Keywords: Lung cancer
Electrocardiogram
Arrhythmia
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective, curatively aimed, primary lung cancer surgery using mini-invasive surgical techniques.

Brief summary: Lung cancer surgery causes significant changes in the small circulation as well as changes in the intrathoracic anatomy. The effects of lung cancer surgery on electrocardiography and the cardiac stress associated with the procedures have not been previously extensively studied. The aim of the present study is to ascertain whether modern mini-invasive lung cancer surgery causes changes in the electrocardiogram, and whether these changes are transitory during short-term follow-up. Furthermore, the study aims to describe whether lung cancer surgery causes significant cardiac stress detectable by intraoperative electrocardiography.

Detailed description: Lung cancer surgery causes significant acute changes in the small circulation as well as both transient and permanent changes in the intrathoracic anatomy. The electrocardiographic changes as well as their associations with postoperative recovery associated with modern mini-invasive lung cancer surgery have not been extensively studied.

The aims of the study are:

1. To define in detail the electrocardiographic changes and their duration caused by lung cancer surgery, both perioperatively and in the early postoperative period
2. To assess, whether perioperative electrocardiographic changes are associated with the postoperative recovery of these patients.

Altogether 100 patients with planned mini-invasive lung cancer surgery in the Tays Heart Hospital, Tampere, Finland, will be prospectively recruited for the study between the years 2021 and 2028.

The 12-lead rest electrocardiogram will be recorded from each patient preoperatively as well daily postoperatively and during follow-up out-patient clinic visit two weeks postoperatively. The perioperative continuous multi-lead electrocardiogram will be recorded. Laboratory examinations (cardiac troponins and natriuretic peptides) indicating cardiac stress will be obtained from the patients preoperatively and repeatedly postoperatively. The variables included in the electrocardiography analysis include cardiac rhythm, heart rate variability, PQ-time, QRS duration, P-, QRS, and T-wave amplitudes and axles, as well as ST-level variations.

Postoperative complications, including cardiac arrhythmias and myocardial ischemia and the duration of postoperative air leak and postoperative chest tube drainage, will be recorded. The associations between lung cancer surgery and electrocardiographic changes, their duration, as well as their associations with postoperative recovery will be analyzed using statistical methods.

A local study registry will be established for the study adhering to the legislature and protocols for clinical studies, including data security. Institutional ethics board committee approval has been obtained. The study will be registered in ClinicalTrials.gov prior to patient enrollment. The study does not include any interventions beside the normal treatment of these patients. Written informed consent will be obtained from each patient. The results of the study will be published in international medical journals.

Eligibility criteria: Inclusion Criteria:

* Adult patients scheduled for elective lung cancer surgery
* Willing to participate in the study
* Curatively aimed surgery
* Preoperative decision for mini-invasive surgery

Exclusion Criteria:

* Participation in any other clinical trial
* Previous chronic or paroxysmal atrial fibrillation or atrial flutter
* Cardiac pacemaker
* History of cardiac conduction disturbances including bundle branch blocks
* History of cardiac ablation procedures
* History of previous surgery in the thoracic area including open heart surgery
* Preoperatively anticipated need for concomitant thoracic wall resection
* Preoperatively anticipated need for open surgery

Primary outcomes:
measure: Postoperative electrocardiographic p-, R-, and T-wave amplitude changes
timeFrame: 2 weeks
measure: Postoperative QRS-duration
timeFrame: 2 weeks
measure: Postoperative PQ-delay
timeFrame: 2 weeks
measure: Postoperative QT-interval
timeFrame: 2 weeks
measure: The postoperative incidence of new bundle branch blocks
timeFrame: 2 weeks
measure: Postoperative ST-level changes
timeFrame: 3 days
measure: Postoperative P-wave, QRS-complex, and T-wave axle changes
timeFrame: 2 weeks
measure: Postoperative heart rate
timeFrame: 1 week
measure: Postoperative arrhythmias
timeFrame: 1 week
measure: Perioperative ST-level changes
timeFrame: 1 day
measure: Perioperative heart rate variability
timeFrame: 1 day
measure: Perioperative arrhythmias
timeFrame: 1 day
measure: Perioperative R- and T-wave amplitude changes
timeFrame: 1 day
Secondary outcomes:
measure: Postoperative air leak
timeFrame: 1 week
measure: Need for reoperation
timeFrame: 1 week
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Heart Hospita, Tampere University Hospital
state: Pirkanmaa
Study officials:
affiliation: MD, PhD
name: Jahangir Khan
role: PRINCIPAL_INVESTIGATOR
References: