Clinical trial NCT03814538: Expiratory Flow Limitation in Thoracic Surgery (EFLinTOR)
Official title: Assessment of the Incidence of Expiratory Flow Limitation in Patients Undergoing Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thoracic Surgery
General Anesthesia
Keywords: Postoperative pulmonary complications
Incidence of EFL
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non critical ill patients (with no high risk of desaturation) undergoing general anesthesia before elective surgery.

Brief 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 (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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of EFL
timeFrame: From the induction of general anesthesia, until the end of the surgical procedure, up to 10 hours
measure: Incidence of postoperative pulmonary complications (PPC) related to EFL
timeFrame: From immediately after surgery until hospital discharge, up to 26 weeks
Secondary outcomes:
measure: Incidence of length of in-hospital stay
timeFrame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of Intensive Care Unit admission and its duration
timeFrame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Duration of mechanical ventilation
timeFrame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of cardiovascular postoperative complications
timeFrame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of neurological postoperative complications
timeFrame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of surgical postoperative complications
timeFrame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of mortality
timeFrame: From immediately after surgery until hospital discharge, up to 26 weeks
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Azienda Ospedaliera-Universitaria di Parma
Study officials:
affiliation: University of Parma
name: Michela Tosi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Parma
name: Benedetta Siroli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Parma
name: Samantha Gorgoglione, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Parma
name: Valentina Bellini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Parma
name: Anna Cozzolino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Parma
name: Cristina Montanino, MD
role: PRINCIPAL_INVESTIGATOR
References: