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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02968550
Other study ID # SEAT
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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