Diabetes MellitusNCT03768973
Pulmonary Effects of Diabetes Mellitus
An observational study of Diabetes Mellitus and Cardiac Surgical Procedures, run by Szeged University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Cardiac Surgical Procedures, Respiratory Mechanics
- What is being tested?
- Elective cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 310 participants
- Where
- 1 siteHungary
- Study dates
- 1 Feb 2019to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients enrolled at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged
Who may be able to join
- Patients undergoing cardiac surgery with or without diabetes mellitus
- age between 18-80 years
Who cannot join
- patients older than 80 years of age or younger than 18 years
- poor ejection fraction (<40%)
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Cardiology Centre Cardiac Surgical Unit and Second Department of Internal Medicine, University of Szeged
Szeged, Csongrád megye, 6725
Barna Babik, MD, PhD, +36 62 542349, babikbarna@gmail.com
Barna Babik, MD, PhD
About this study
Official title: Pulmonary Effects of Diabetes Mellitus in Anesthetized Mechanically Ventilated 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. 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.
Read the detailed description
One hour before the surgery, patients are premedicated with lorazepam (per os, 2.5 mg). Induction of anaesthesia is achieved by iv midazolam (30 μg/kg), sufentanyl (0.4-0.5 μg/kg), and propofol (0.3-0.5 mg/kg), and iv propofol (50 mg/kg/min) is administered to maintain anaesthesia. Intravenous boluses of rocuronium (0.6 mg/kg for induction and 0.2 mg/kg every 30 minutes for maintenance) is administered iv to ensure neuromuscular blockade. A cuffed tracheal tube (internal diameter of 7, 8, or 9 mm) is used for tracheal intubation, and patients are mechanically ventilated (Dräger Zeus, Lübeck, Germany) in volume-controlled mode with decelerating flow. A tidal volume of 7 ml/kg and a positive end-expiratory pressure of 4 cmH2O are applied, and the ventilation frequency is adjusted to 12-14 breaths/min to maintain end-tidal CO2 partial pressure of 36 38 mmHg. Mechanical ventilation is performed with a fraction of inspired oxygen of 0.5 before CPB, and it is increased to 0.8 after CPB. As a standard part of the cardiac anaesthesia procedure, oesophageal and rectal temperature probes are introduced, and a central venous line is inserted into the right jugular vein. The left radial artery is also cannulated to monitor systolic, diastolic and mean arterial (MAP) blood pressures and arterial blood gas samples.
The membrane oxygenator is primed with 1,500 ml lactated Ringer's solution prior to CPB. Intravenous heparin (300 U/kg) is injected into the patient, to achieve an activated clotting time of 400 s during CPB procedures. During CPB, mild hypothermia is allowed, the mechanical ventilation is stopped, and the ventilator is disconnected without applying positive airway pressure. Before restoring ventilation, the lungs are inflated 3-5 times to a peak airway pressure of 30 cmH2O to facilitate lung recruitment.
A flow meter and a mainstream capnometer is to be inserted into the breathing circuit between the endotracheal tube and the Y-piece of the breathing circuit to record capnogram curves. a T-piece with 2 collapsible segments is attached to the distal tracheal tube, with one end connected to the respirator and the other end to a loudspeaker-in-box system (FOT system) to measure respiratory mechanics by the use of forced oscillations. During normal ventilation the FOT system is not communicating with the patient, however, during measurements of respiratory mechanics the ventilator is to be stopped at end-expiration and the breathing circuit is blocked in a way that allows a connection between the FOT system and the patient. During a 15-s long apnoeic period respiratory mechanical parameters are to be measured with the FOT system and then normal ventilation is to be restored. Capnogram curves are going to be recorded and respiratory mechanical parameters are going to be measured a) after anaesthesia induction with the chest wall still intact, b) following chest wall opening before CPB initiation, c) following CPB with the chest wall open and d) following sternal closure before end of surgery in all groups of patients. Arterial and venous blood gas samples are also going to be collected at these time points.
Sample sizes are estimated to enable the detection of a 15% difference in the primary outcome parameter, the lung tissue elastance. Accordingly, sample-size estimation based on an ANOVA test with two groups of patients indicated that 155 patients were required in each group to detect a significant difference between the protocol groups (the assumed variability of 30%, power of 80% and the significance level of 5%).
Two-way repeated measures ANOVA with the inclusion of an interaction term is used for all measured variables with the protocol stage as within-subject factor (protocol stages) and group allocation as between-subject factor to establish the effects of T2DM and the surgical procedure on the measured respiratory mechanical and capnography indices. At half-way of the data collection, an interim analyses will be performed and the further data collection will be proceeded based on the results of this analysis.
- Being tested
- Elective cardiac surgery
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective cardiac surgeryProcedure or surgery
Both groups will undergo elective cardiac surgery as an intervention.
| Study group | Role | What they receive |
|---|---|---|
| Group T2DM | Patients with diabetes mellitus undergoing elective cardiac surgery Receives: Procedure: Elective cardiac surgery | |
| Group Ctrl | Control patients undergoing elective cardiac surgery without T2DM Receives: Procedure: Elective cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: : Intraoperative interval during cardiac surgery starting from anaesthesia induction until end of the surgery. (approx. 180 minutes, measurements at ~10-40-140-160 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Feb 2019
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Collaborators
- Hungarian Basic Research Council, GINOP
- Responsible party
- Principal investigator, Barna Babik, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768973
- Sponsor's protocol ID
- WHO2788-a
- Status last verified
- May 2019
- First submitted
- 29 Nov 2018
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Effects of Diabetes Mellitus in Anesthetized Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT03768973
- Acronym / sponsor ID
- WHO2788-a
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Collaborators
- Hungarian Basic Research Council, GINOP
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One hour before the surgery, patients are premedicated with lorazepam (per os, 2.5 mg). Induction of anaesthesia is achieved by iv midazolam (30 μg/kg), sufentanyl (0.4-0.5 μg/kg), and propofol (0.3-0.5 mg/kg), and iv propofol (50 mg/kg/min) is administered to maintain anaesthesia. Intravenous boluses of rocuronium (0.6 mg/kg for induction and 0.2 mg/kg every 30 minutes for maintenance) is administered iv to ensure neuromuscular blockade. A cuffed tracheal tube (internal diameter of 7, 8, or 9 mm) is used for tracheal intubation, and patients are mechanically ventilated (Dräger Zeus, Lübeck, Germany) in volume-controlled mode with decelerating flow. A tidal volume of 7 ml/kg and a positive end-expiratory pressure of 4 cmH2O are applied, and the ventilation frequency is adjusted to 12-14 breaths/min to maintain end-tidal CO2 partial pressure of 36 38 mmHg. Mechanical ventilation is performed with a fraction of inspired oxygen of 0.5 before CPB, and it is increased to 0.8 after CPB. As a standard part of the cardiac anaesthesia procedure, oesophageal and rectal temperature probes are introduced, and a central venous line is inserted into the right jugular vein. The left radial artery is also cannulated to monitor systolic, diastolic and mean arterial (MAP) blood pressures and arterial blood gas samples.
The membrane oxygenator is primed with 1,500 ml lactated Ringer's solution prior to CPB. Intravenous heparin (300 U/kg) is injected into the patient, to achieve an activated clotting time of 400 s during CPB procedures. During CPB, mild hypothermia is allowed, the mechanical ventilation is stopped, and the ventilator is disconnected without applying positive airway pressure. Before restoring ventilation, the lungs are inflated 3-5 times to a peak airway pressure of 30 cmH2O to facilitate lung recruitment.
A flow meter and a mainstream capnometer is to be inserted into the breathing circuit between the endotracheal tube and the Y-piece of the breathing circuit to record capnogram curves. a T-piece with 2 collapsible segments is attached to the distal tracheal tube, with one end connected to the respirator and the other end to a loudspeaker-in-box system (FOT system) to measure respiratory mechanics by the use of forced oscillations. During normal ventilation the FOT system is not communicating with the patient, however, during measurements of respiratory mechanics the ventilator is to be stopped at end-expiration and the breathing circuit is blocked in a way that allows a connection between the FOT system and the patient. During a 15-s long apnoeic period respiratory mechanical parameters are to be measured with the FOT system and then normal ventilation is to be restored. Capnogram curves are going to be recorded and respiratory mechanical parameters are going to be measured a) after anaesthesia induction with the chest wall still intact, b) following chest wall opening before CPB initiation, c) following CPB with the chest wall open and d) following sternal closure before end of surgery in all groups of patients. Arterial and venous blood gas samples are also going to be collected at these time points.
Sample sizes are estimated to enable the detection of a 15% difference in the primary outcome parameter, the lung tissue elastance. Accordingly, sample-size estimation based on an ANOVA test with two groups of patients indicated that 155 patients were required in each group to detect a significant difference between the protocol groups (the assumed variability of 30%, power of 80% and the significance level of 5%).
Two-way repeated measures ANOVA with the inclusion of an interaction term is used for all measured variables with the protocol stage as within-subject factor (protocol stages) and group allocation as between-subject factor to establish the effects of T2DM and the surgical procedure on the measured respiratory mechanical and capnography indices. At half-way of the data collection, an interim analyses will be performed and the further data collection will be proceeded based on the results of this analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T2DM | – | Procedure: Elective cardiac surgeryPatients with diabetes mellitus undergoing elective cardiac surgery |
| Group Ctrl | – | Procedure: Elective cardiac surgeryControl patients undergoing elective cardiac surgery without T2DM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients enrolled at the Second Department of Internal Medicine and Cardiology Centre Cardiac Surgical Unit, University of Szeged
Key inclusion criteria (2 listed)
- Patients undergoing cardiac surgery with or without diabetes mellitus
- age between 18-80 years
Key exclusion criteria (2 listed)
- patients older than 80 years of age or younger than 18 years
- poor ejection fraction (<40%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective cardiac surgeryBoth groups will undergo elective cardiac surgery as an intervention. | Procedure or surgery | Group Ctrl, Group T2DM |
Primary outcome
Changes in lung input impedance and mechanical parameters
Time frame: 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 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.
Changes of exhaled CO2 partial pressure curve shape factors
Time frame: 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 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.
Changes in intrapulmonary shunt fraction
Time frame: : Intraoperative interval during cardiac surgery starting from anaesthesia induction until end of the surgery. (approx. 180 minutes, measurements at ~10-40-140-160 minutes)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Cardiac Surgical Procedures, run by Szeged University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barna Babik, MD, PhD (+36 62 542349, babikbarna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lung input impedance and mechanical parameters (time frame: Intraoperative interval during cardiac surgery starting from anaesthesia induction until end of the surgery. (approx. 180 minutes, measurements at ~10-40-140-160 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.