Seasonal Trends of Respiratory Morbidity in Diabetic Patients

Retrospective Analysis of Seasonal Trends of Respiratory Morbidity in Diabetic Patients

Type 2 diabetes mellitus (T2DM) poses a significant burden on the patients and the health care system. The increasing number of surgery performed in elderly population results in an increased number of perioperative T2DM-related adverse effects. T2DM has a prevalence of 30-40% in a population undergoing cardiovascular surgery. Cardiac surgery, especially cardiopulmonary bypass (CPB) is also known to deteriorate respiratory mechanics.

Therefore, the study is aimed at a retrospective analysis of seasonal trends in respiratory consequences of T2DM, i.e.: i: distribution of patients with and without T2DM presenting for elective cardiac surgery during the two-year examination period; ii: characterization of respiratory co-morbidities in the patients, iii: exploring whether the respiratory mechanics at presentation and those caused by cardiac surgery exhibit different trends in T2DM and control patients.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus; Perioperative/Postoperative Complications; Respiratory Complication
• Intervention / Treatment: Procedure: Elective cardiac surgery

Detailed Description

Our study is a retrospective analysis of patient records from all patients undergoing elective cardiac surgery between January 2007 to December 2018 at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged.

Electronic and paper documentation will be examined and anonymously analysed for the following information:

1. date of cardiac surgery,
2. type of cardiac surgery procedure,
3. demographic data (age, height, weight),
4. presence of T2DM (previous diagnosis, fasting plasma glucose level, glycated haemoglobin [HbA1C]),
5. presence of respiratory co-morbidities (e.g. asthma, COPD, etc.),
6. presence of other circulatory co-mobidities (e.g. hypertension, previous stroke, vascular stenosis)

6. respiratory mechanical parameters before and after cardiac surgery, 7. presence of perioperative respiratory complications, 8. history of smoking 9. blood gas measurements before, during and after surgery

Time series statistical analysis of all data will be carried out to discover the presence of seasonal trends in both diabetic and control patients. Analysis of variance (ANOVA) will be carried out to explore global differences between diabetic and control patients.

• Study Type: Observational
• Enrollment (Anticipated): 9838

Contacts and Locations

Study Locations

• Hungary
  • Csongrad Megye
    • Szeged, Csongrad Megye, Hungary, 6725
      • Cardiology Centre Cardiac Surgical Unit and Second Department of Internal Medicine, University of Szeged

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Retrospective analysis of patient records from all patients undergoing elective cardiac surgery between January 2007 to December 2018 at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged

Description

Inclusion Criteria:

• all patients undergoing cardiac surgery with or without diabetes mellitus, age between 18-85 years during the time period January 2007 to December 2018

Exclusion Criteria:

• patients older than 85 years
• patients younger than 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group T2DM; Patients with diabetes mellitus undergoing elective cardiac surgery	Procedure: Elective cardiac surgery; Elective cardiac surgery
Group Ctrl; Control patients undergoing elective cardiac surgery without T2DM	Procedure: Elective cardiac surgery; Elective cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seasonal variation in the incidence of diabetic patients undergoing cardiac surgery	All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. The relative incidence of diabetic patients will be evaluated on a monthly basis in the study period.	Retrospective data analysis (2006-2018)
Anthropometric data of patients undergoing cardiac surgery	All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. Anthropometric data will be collected from the patient records: height (meters) and weight (kilograms) of each patient will be collected from the hospital medical records, then these data will be combined to report BMI (kg/m^2).	Retrospective data analysis (2006-2018)
Comorbidities of diabetic patients undergoing cardiac surgery	All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. Co-morbidities (COPD, asthma, hypertension, etc.) of each patient will be collected from the hospital medical records.	Retrospective data analysis (2006-2018)
Smoking habits of patients undergoing cardiac surgery	All patient data from the time period 2006-2018 will be retrospectively analysed to explore the seasonal trends of diabetic patients (Type 1 and Type 2) undergoing cardiac surgery at a university hospital setting. Reported smoking habits (present smoker/previous smoker/never smoker; number of packs / day; duration) of each patient will be collected from the hospital medical records.	Retrospective data analysis (2006-2018)

Collaborators and Investigators

• Sponsor: Szeged University
• Collaborators: Hungarian Basic Research Council; GINOP
• Investigators: Principal Investigator: Barna Babik, MD, PhD, Szeged University

Publications and helpful links

General Publications

• Peták F, Kovács BN, Agócs S, Virág K, Nyári T, Molnár A, Südy R, Lengyel C, Babik B. Seasonal changes in proportion of cardiac surgeries associated with diabetes, smoking and elderly age. PLoS One. 2022 Sep 22;17(9):e0274105. doi: 10.1371/journal.pone.0274105. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 30, 2019
• Last Update Submitted That Met QC Criteria: May 27, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: respiratory mechanics; cardiac surgical procedures; seasonal variation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: WHO2788-c

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No