Shunt Evaluation With ALPE System in Thoracic Surgery

Mechanical Ventilation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968550
• Other study ID #: SEAT
• Status: Completed
• Phase: N/A
• First received: November 8, 2016
• Last updated: March 29, 2017
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Università degli Studi di Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

. The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress during one lung ventilation (OLV) at different levels of positive end expiratory pressure (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during OLV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients scheduled for thoracoscopic lobectomy or thoracoscopic wedge resection in lateral decubitus.

• patients American Society of Anesthesiologists Physical Status Classi?cation score of 1-3

Exclusion Criteria:

• Patients with hemodynamic instability,

• Patients with severe chronic respiratory failure

• Patients with preoperative anemia (hemoglobin <10 g 100 ml-1)

• Patients requiring unplanned conversion to thoracotomy

Related Conditions & MeSH terms

• Mechanical Ventilation
• Thoracic Diseases

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Sant'Anna	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Beck DH, Doepfmer UR, Sinemus C, Bloch A, Schenk MR, Kox WJ. Effects of sevoflurane and propofol on pulmonary shunt fraction during one-lung ventilation for thoracic surgery. Br J Anaesth. 2001 Jan;86(1):38-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary shunt evaluated with ALPE system		every 30 minutes after the start of surgery up to 3 evaluations, up to 90 minutes
Secondary	predictors of high intraoperative shunt	All patients admitted to the study received a preoperative physiologic assessment with a cardiovascular evaluation and spirometry. After 15 minutes of one lung ventilation, the pulmonary shunt is evaluated. Therefore, all clinical variable evaluated during preoperative assessment will be compared with the pulmonary shunt	The outcome is assessed 15 minutes after one lung ventilation