Pulmonary Effects of Diabetes Mellitus
1 other identifier
observational
310
1 country
1
Brief Summary
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. The vascular effects of T2DM are well characterized, however, its effects on the mechanical properties of the respiratory system or the exhaled carbon-dioxide concentration curve (capnogram) during and following CPB are yet to be fully discovered. Therefore, the study is aimed at characterizing the respiratory consequences of T2DM, i.e.: i: deteriorations of airway function that might be a result of smooth muscle dysfunction; ii: deterioration of the viscoelastic properties of the lung as a result of lung volume loss or structural changes, iii: exploring whether the changes of respiratory mechanics caused by cardiac surgery exhibit a different time course in T2DM and control patients. The study also aims at characterizing the effects of T2DM on capnogram parameters: i: whether it influences capnogram shape factors, ii: whether any differences can be detected in the dead-space parameters and iii: whether cardiac surgery has a different effect on capnogram parameters in T2DM patients compared to controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2018
CompletedFirst Posted
Study publicly available on registry
December 7, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMay 16, 2019
May 1, 2019
1.3 years
November 29, 2018
May 14, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Changes in lung input impedance and mechanical parameters
Changes in the airway and tissue mechanical properties are assessed by measuring the input impedance of the lungs. Briefly, a T-piece with 2 collapsible segments is attached to the tracheal tube, with one end connected to the respirator and the other to a loudspeaker-in-box system. This makes it possible to switch the patient from the respirator to the forced oscillatory setup during the measurements. The measurements are performed by introducing pseudorandom pressure excitations generated by the loudspeaker into the trachea during short (15s) apnoeic pauses introduced into the mechanical ventilation. Lung input impedance is computed from the power spectra of airway opening pressure and tracheal airflow and then averaged under each condition. The measured lung impedance data are fitted using a 4-element model consisting of a frequency-independent airway resistance and inertance and a constant-phase tissue compartment characterized by the coefficients of damping and elastance.
Intraoperative interval during cardiac surgery starting from anaesthesia induction until end of the surgery. (approx. 180 minutes, measurements at ~10-40-140-160 minutes)
Changes of exhaled CO2 partial pressure curve shape factors
Changes in CO2 partial pressure in the exhaled gas during mechanical ventilation are measured with a calibrated mainstream capnograph (Capnogard Model 1265, Novametrix). A 28-mm internal diameter screen pneumotachograph connected to a differential pressure transducer (ICS model 33NA002D; IC Sensors) is used to measure airflow. The measured signals are digitized and stored on a computer. A custom-made software is used to determine parameters of this curve. The exhaled CO2 partial pressure is expressed both as a function of time (time domain) and as a function of exhaled volume (volumetric domain). Shape factors and dead-space indices of the recorded CO2 partial pressure curves are to be determined both from time and volumetric domains.
Intraoperative interval during cardiac surgery starting from anaesthesia induction until end of the surgery. (approx. 180 minutes, measurements at ~10-40-140-160 minutes)
Changes in intrapulmonary shunt fraction
To measure intrapulmonary shunt fraction, arterial and central venous blood gas samples are going to be obtained. The partial pressure of oxygen and carbon-dioxide in these blood samples is to be determined alongside pH and ion concentrations by radiometric blood gas analysis. Intrapulmonary shunt fraction is going to be calculated from the oxygen content of these arterial and central venous blood samples.
: Intraoperative interval during cardiac surgery starting from anaesthesia induction until end of the surgery. (approx. 180 minutes, measurements at ~10-40-140-160 minutes)
Study Arms (2)
Group T2DM
Patients with diabetes mellitus undergoing elective cardiac surgery
Group Ctrl
Control patients undergoing elective cardiac surgery without T2DM
Interventions
Both groups will undergo elective cardiac surgery as an intervention.
Eligibility Criteria
The patients enrolled at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged
You may qualify if:
- Patients undergoing cardiac surgery with or without diabetes mellitus
- age between 18-80 years
You may not qualify if:
- patients older than 80 years of age or younger than 18 years
- poor ejection fraction (\<40%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Szeged Universitylead
- Hungarian Basic Research Councilcollaborator
- GINOPcollaborator
Study Sites (1)
Cardiology Centre Cardiac Surgical Unit and Second Department of Internal Medicine, University of Szeged
Szeged, Csongrád megye, 6725, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 29, 2018
First Posted
December 7, 2018
Study Start
February 1, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
May 16, 2019
Record last verified: 2019-05