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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03184974
Other study ID # PEEPOPTIMA
Secondary ID
Status Completed
Phase N/A
First received June 9, 2017
Last updated March 6, 2018
Start date October 1, 2015
Est. completion date November 1, 2016

Study information

Verified date March 2018
Source Fundación para la Investigación del Hospital Clínico de Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

During thoracic surgical procedures, while ventilating with a protective tidal volume, an open lung approach consisting of a recruitment maneuver followed by an individualized positive end-expiratory pressure (PEEP) titrated to best respiratory system compliance (Open-lung PEEP, OL-PEEP) would decrease driving pressure. To test this hypothesis, we performed a multicenter observational study in 17 Spanish teaching hospitals of patients undergoing one lung ventilation (OLV). In addition, we analyzed the association between the driving pressure and the prevalence of postoperative pulmonary complications (PPCs), and finally the association between the individualized PEEP and relevant patient preoperative or intraoperative variables.


Recruitment information / eligibility

Status Completed
Enrollment 690
Est. completion date November 1, 2016
Est. primary completion date October 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing one lung ventilation

Exclusion Criteria:

- No exclusion criteria

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pulmonary complications Atelectasis, acute respiratory failure, ARDS, pneumonia, reintubation, empyema, bronchospasm, pneumothorax, pneumonitis, bronchopleural fistula Postoperative. One week
Secondary Descriptive analysis of the open lung PEEP Open lung PEEP is the PEEP of best dynamic respiratory system compliance during a PEEP titration trial intraoperative
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