Expiratory Flow Limitation in Thoracic Surgery (EFLinTOR)

NCT03814538 | Unknown

• 1 other identifier: 876/2018/OSS/AOUPR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Surgery; General Anesthesia

Keywords

Postoperative pulmonary complications; Incidence of EFL

Outcome Measures

Primary Outcomes (2)

• Incidence of EFL

  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

  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 Outcomes (7)

• Incidence of length of in-hospital stay

  From immediately after surgery until hospital discharge, up to 26 weeks

• Incidence of Intensive Care Unit admission and its duration

  From immediately after surgery until hospital discharge, up to 26 weeks

• Duration of mechanical ventilation

  From immediately after surgery until hospital discharge, up to 26 weeks

• Incidence of cardiovascular postoperative complications

  From immediately after surgery until hospital discharge, up to 26 weeks

• Incidence of neurological postoperative complications

  From immediately after surgery until hospital discharge, up to 26 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

non critical ill patients (with no high risk of desaturation) undergoing general anesthesia before elective surgery.

You may qualify if:

• age \>18 years old
• signed informed consent
• elective thoracic surgery
• planned thoracic surgery with thoracotomy and thoracosthomy

You may not qualify if:

• Patient refusal
• Pregnancy
• Patients undergoing emergency or emergency surgery
• Patients underwent cardiac and surgery
• patients underwent thoracic surgery with median sthernotomy

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Azienda Ospedaliera-Universitaria di Parma

Parma, 43125, Italy

RECRUITING

Study Officials

• Michela Tosi, MD

  University of Parma

  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

• Anna Cozzolino, MD

  University of Parma

  PRINCIPAL INVESTIGATOR

• Cristina Montanino, MD

  University of Parma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Giovann Bignami, Professor

CONTACT

+390521033609; elenagiovanna.bignami@unipr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 24, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

IT (1)