- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03814538
Expiratory Flow Limitation in Thoracic Surgery (EFLinTOR) ((EFLinTOR))
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Elena Giovann Bignami, Professor
- Phone Number: +390521033609
- Email: elenagiovanna.bignami@unipr.it
Study Locations
-
-
-
Parma, Italy, 43125
- Recruiting
- Azienda Ospedaliera-Universitaria di Parma
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age >18 years old
- signed informed consent
- elective thoracic surgery
- planned thoracic surgery with thoracotomy and thoracosthomy
Exclusion Criteria:
- Patient refusal
- Pregnancy
- Patients undergoing emergency or emergency surgery
- Patients underwent cardiac and surgery
- patients underwent thoracic surgery with median sthernotomy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
From immediately after surgery until hospital discharge, up to 26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of cardiovascular postoperative complications
Time Frame: From immediately after surgery until hospital discharge, up to 26 weeks
|
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
|
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
|
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
|
From immediately after surgery until hospital discharge, up to 26 weeks
|
Incidence of length of in-hospital stay
Time Frame: From immediately after surgery until hospital discharge, up to 26 weeks
|
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
|
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
|
From immediately after surgery until hospital discharge, up to 26 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benedetta Siroli, MD, University of Parma
- Principal Investigator: Samantha Gorgoglione, MD, University of Parma
- Principal Investigator: Valentina Bellini, MD, University of Parma
- Principal Investigator: Michela Tosi, MD, University of Parma
- Principal Investigator: Anna Cozzolino, MD, University of Parma
- Principal Investigator: Cristina Montanino, MD, University of Parma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 876/2018/OSS/AOUPR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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