Open Lung PEEP in Thoracic Surgery

Thoracic Surgery Clinical Trial

Official title:

Individualized Open Lung PEEP in Thoracic Surgery: A Prospective Multicenter Observational Study in 17 Spanish Hospitals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184974
• Other study ID #: PEEPOPTIMA
• 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
• 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

Related Conditions & MeSH terms

• Thoracic Surgery
• Ventilation Therapy; Complications

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