Thoracic Surgery(EFLinTOR)NCT03814538
Expiratory Flow Limitation in Thoracic Surgery (EFLinTOR)
An observational study of Thoracic Surgery and General Anesthesia, run by University of Parma at 1 site in Italy.
Trial summary
Background and rationale of the study: During general anesthesia, the residual functional capacity (FRC) is reduced. If the FRC is lower than the minimum volume necessary to maintain the airway opening (closing capacity, CC), a pulmonary parenchyma derecruitment leads to the phenomenon of expiratory flow limitation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery, General Anesthesia
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 1 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: non critical ill patients (with no high risk of desaturation) undergoing general anesthesia before elective surgery.
Who may be able to join
- age >18 years old
- signed informed consent
- elective thoracic surgery
- planned thoracic surgery with thoracotomy and thoracosthomy
Who cannot join
- Patient refusal
- Pregnancy
- Patients undergoing emergency or emergency surgery
- Patients underwent cardiac and surgery
- patients underwent thoracic surgery with median sthernotomy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera-Universitaria di Parma
Parma, 43125
Elena Giovanna Bignami, MD Professor, +390521703567, elenagiovanna.bignami@unipr.it
About this study
Official title: Assessment of the Incidence of Expiratory Flow Limitation in Patients Undergoing Thoracic Surgery
Background and rationale of the study: During general anesthesia, the residual functional capacity (FRC) is reduced. If the FRC is lower than the minimum volume necessary to maintain the airway opening (closing capacity, CC), a pulmonary parenchyma derecruitment leads to the phenomenon of expiratory flow limitation (EFL). In recent years, new methods are being studied to assess EFL. In the study by Marangoni E, et. al., has been shown how the sudden subtraction of 3 cmH2O to the value of the tele-expiratory positive pressure (PEEP test) is sufficient to establish the presence of the EFL.
The presence of EFL measured by this method seems to correlate, in abdominal surgery, with the development of post-operative pulmonary complications. In the area of anesthesia in thoracic surgery, neither the incidence nor the relevance of the EFL are known, so a study is needed that evaluates both.
Read more
The aim of the study is to determine the incidence of expiratory flow limitation in patients undergoing thoracic surgery and ventilated in bi and monopolmonary mode.
The protective ventilation is a mechanical ventilation with a current volume (TV) of 6-8 mL / kg among to the ideal body weight (IBW), PEEP of 3-5 cmH2O and a FiO2 <80%.
The aim of this study is to evaluate the incidence of EFL in patients undergoing thoracic surgery, planned by thoracoscopy and thoracotomy in election, and to correlate this parameter with the onset of postoperative pulmonary complications. The final aim will be to verify if it is possible to identify a better approach, through the personalization of mechanical ventilation during the surgery, to reduce mortality, morbidity and hospital stay after thoracic surgery.
Read the detailed description
It's a prospective and observational study, with 100 patients that undergo thoracic surgery.
The respiratory rate will be set to maintain PaCO2 at values close to eucapnia.
Controlled pressure ventilation (Pinsp ≤ 35 cmH2O) will be used only if the maximum airway pressures are reached and exceeded with controlled ventilation.
The inspiratory mixture will consist of O2: Air and possibly the halogenated anesthetic.
At the end of the operation, the patients will be transferred to Intensive Care Unit for post-operative monitoring. During the transfer will be supported with mechanical ventilation manually performed by the Anesthesiologist.
The extubation will be performed in TICCH, according to the practice of the center.
Patients will be asked to join the study by giving informed consent.
The data will be collected through a special data collection form (Case Report Form, CRF).
The following information will be collected:
In the section dedicated to the preoperative patient data will be inserted related to:
- age, weight, height, sex;
- general health conditions
- previous and concurrent diseases
- positive respiratory history for: previous pleuro-parenchymal diseases in the 30 days prior to surgery, previous interventions on the thorax, pleura or lung, presence of pleural effusion; asthma; Chronic obstructive pulmonary disease.
- history of cigarette smoking: active smoker (number of cigarettes), ex-smoker or non-smoker;
- Preoperative Therapy
- SpO2, PaO2, PaO2 / FiO2, PaCO2 (if available);
- cardiological anamnesis (echocardiography, ECG, etc.) other medical information relevant to the study
The following data will be collected on the intra-operative card:
- incidence of EFL and respiratory mechanics parameters, collected by the ventilator;
- type of surgical intervention;
- transfusion of blood derivatives;
- eventual administration of cardio / vasoactive drugs;
- duration of the surgery; other information related to the intra-operative relevant for the purpose of the study
The EFL will be registered at the following time-points:
- after the induction of anesthesia;
- after lateral positioning of the patient;
- start of One Lung Ventilation;
- 5 ' after cutting skin;
- 30 ' after cutting skin;
- 5 ' after closing skin;
- Bipulmonary ventilation;
- Positioning of the back of the patient.
The following data will be recorded in the postoperative card:
- Post-operative mechanical ventilation time
- postoperative respiratory complications;
- postoperative non-respiratory (cardiovascular, infectious, renal, surgical) complications;
- need for re-intubation in the postoperative period;
- need for ventilatory support (non-invasive ventilation, invasive ventilation) in the postoperative period;
- need for hospitalization in intensive care (expected, unexpected, cause of hospitalization, length of stay);
- duration of hospital stay; other postoperative information relevant for the purpose of the study.
Data will be analyzed using statistical software.
- Conditions
- Thoracic Surgery, General Anesthesia
- Keywords
- Postoperative pulmonary complications, Incidence of EFL
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of EFL
Evaluate the incidence of the EFL in patients undergoing thoracic surgery
Measured: From the induction of general anesthesia, until the end of the surgical procedure, up to 10 hours
Incidence of postoperative pulmonary complications (PPC) related to EFL
Evaluate the relationship between the incidence of EFL and the onset of PPC in patients undergoing thoracic surgery
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Secondary outcomes (7)
Incidence of length of in-hospital stay
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of Intensive Care Unit admission and its duration
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Duration of mechanical ventilation
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of cardiovascular postoperative complications
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of neurological postoperative complications
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of surgical postoperative complications
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of mortality
Measured: From immediately after surgery until hospital discharge, up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Giovanna Bignami, University of Parma
- Investigators
- Michela Tosi, MD, Principal investigator, University of ParmaBenedetta Siroli, MD, Principal investigator, University of ParmaSamantha Gorgoglione, MD, Principal investigator, University of ParmaValentina Bellini, MD, Principal investigator, University of ParmaAnna Cozzolino, MD, Principal investigator, University of ParmaCristina Montanino, MD, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814538
- Sponsor's protocol ID
- 876/2018/OSS/AOUPR
- Acronym
- (EFLinTOR)
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Incidence of Expiratory Flow Limitation in Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03814538
- Acronym / sponsor ID
- (EFLinTOR) / 876/2018/OSS/AOUPR
- Conditions
- Thoracic Surgery, General Anesthesia
- Keywords
- Postoperative pulmonary complications, Incidence of EFL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 24 Jan 2019 (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.
Background and rationale of the study: During general anesthesia, the residual functional capacity (FRC) is reduced. If the FRC is lower than the minimum volume necessary to maintain the airway opening (closing capacity, CC), a pulmonary parenchyma derecruitment leads to the phenomenon of expiratory flow limitation (EFL). In recent years, new methods are being studied to assess EFL. In the study by Marangoni E, et. al., has been shown how the sudden subtraction of 3 cmH2O to the value of the tele-expiratory positive pressure (PEEP test) is sufficient to establish the presence of the EFL.
The presence of EFL measured by this method seems to correlate, in abdominal surgery, with the development of post-operative pulmonary complications. In the area of anesthesia in thoracic surgery, neither the incidence nor the relevance of the EFL are known, so a study is needed that evaluates both.
The aim of the study is to determine the incidence of expiratory flow limitation in patients undergoing thoracic surgery and ventilated in bi and monopolmonary mode.
The protective ventilation is a mechanical ventilation with a current volume (TV) of 6-8 mL / kg among to the ideal body weight (IBW), PEEP of 3-5 cmH2O and a FiO2 <80%.
The aim of this study is to evaluate the incidence of EFL in patients undergoing thoracic surgery, planned by thoracoscopy and thoracotomy in election, and to correlate this parameter with the onset of postoperative pulmonary complications. The final aim will be to verify if it is possible to identify a better approach, through the personalization of mechanical ventilation during the surgery, to reduce mortality, morbidity and hospital stay after thoracic surgery.
Detailed description
It's a prospective and observational study, with 100 patients that undergo thoracic surgery.
The respiratory rate will be set to maintain PaCO2 at values close to eucapnia.
Controlled pressure ventilation (Pinsp ≤ 35 cmH2O) will be used only if the maximum airway pressures are reached and exceeded with controlled ventilation.
The inspiratory mixture will consist of O2: Air and possibly the halogenated anesthetic.
At the end of the operation, the patients will be transferred to Intensive Care Unit for post-operative monitoring. During the transfer will be supported with mechanical ventilation manually performed by the Anesthesiologist.
The extubation will be performed in TICCH, according to the practice of the center.
Patients will be asked to join the study by giving informed consent.
The data will be collected through a special data collection form (Case Report Form, CRF).
The following information will be collected:
In the section dedicated to the preoperative patient data will be inserted related to:
- age, weight, height, sex;
- general health conditions
- previous and concurrent diseases
- positive respiratory history for: previous pleuro-parenchymal diseases in the 30 days prior to surgery, previous interventions on the thorax, pleura or lung, presence of pleural effusion; asthma; Chronic obstructive pulmonary disease.
- history of cigarette smoking: active smoker (number of cigarettes), ex-smoker or non-smoker;
- Preoperative Therapy
- SpO2, PaO2, PaO2 / FiO2, PaCO2 (if available);
- cardiological anamnesis (echocardiography, ECG, etc.) other medical information relevant to the study
The following data will be collected on the intra-operative card:
- incidence of EFL and respiratory mechanics parameters, collected by the ventilator;
- type of surgical intervention;
- transfusion of blood derivatives;
- eventual administration of cardio / vasoactive drugs;
- duration of the surgery; other information related to the intra-operative relevant for the purpose of the study
The EFL will be registered at the following time-points:
- after the induction of anesthesia;
- after lateral positioning of the patient;
- start of One Lung Ventilation;
- 5 ' after cutting skin;
- 30 ' after cutting skin;
- 5 ' after closing skin;
- Bipulmonary ventilation;
- Positioning of the back of the patient.
The following data will be recorded in the postoperative card:
- Post-operative mechanical ventilation time
- postoperative respiratory complications;
- postoperative non-respiratory (cardiovascular, infectious, renal, surgical) complications;
- need for re-intubation in the postoperative period;
- need for ventilatory support (non-invasive ventilation, invasive ventilation) in the postoperative period;
- need for hospitalization in intensive care (expected, unexpected, cause of hospitalization, length of stay);
- duration of hospital stay; other postoperative information relevant for the purpose of the study.
Data will be analyzed using statistical software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non critical ill patients (with no high risk of desaturation) undergoing general anesthesia before elective surgery.
Key inclusion criteria (4 listed)
- age >18 years old
- signed informed consent
- elective thoracic surgery
- planned thoracic surgery with thoracotomy and thoracosthomy
Key exclusion criteria (5 listed)
- Patient refusal
- Pregnancy
- Patients undergoing emergency or emergency surgery
- Patients underwent cardiac and surgery
- patients underwent thoracic surgery with median sthernotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of EFL
Time frame: From the induction of general anesthesia, until the end of the surgical procedure, up to 10 hours
Evaluate the incidence of the EFL in patients undergoing thoracic surgery
Incidence of postoperative pulmonary complications (PPC) related to EFL
Time frame: From immediately after surgery until hospital discharge, up to 26 weeks
Evaluate the relationship between the incidence of EFL and the onset of PPC in patients undergoing thoracic surgery
7 secondary outcomes
Incidence of length of in-hospital stay
Time frame: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of Intensive Care Unit admission and its duration
Time frame: From immediately after surgery until hospital discharge, up to 26 weeks
Duration of mechanical ventilation
Time frame: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of cardiovascular postoperative complications
Time frame: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of neurological postoperative complications
Time frame: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of surgical postoperative complications
Time frame: From immediately after surgery until hospital discharge, up to 26 weeks
Incidence of mortality
Time frame: From immediately after surgery until hospital discharge, up to 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
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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.
Michela Tosi, MD principal investigator
University of Parma
Benedetta Siroli, MD principal investigator
University of Parma
Samantha Gorgoglione, MD principal investigator
University of Parma
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 Thoracic Surgery and General Anesthesia, run by University of Parma at 1 site in Italy.
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 4 inclusion and 5 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 24 Jan 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 Italy. 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 Elena Giovann Bignami, Professor (+390521033609, elenagiovanna.bignami@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of EFL (time frame: From the induction of general anesthesia, until the end of the surgical procedure, up to 10 hours). The study lists 2 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 24 Jan 2019.