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CompletedNCT03184974Updated Mar 7, 2018

Open Lung PEEP in Thoracic Surgery

An observational study in Thoracic Surgery and Ventilation Therapy; Complications, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
690
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Thoracic Surgery
  • Ventilation Therapy; Complications

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03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's enrollment of 690 is above the median of 183 across 180 observational studies indexed under Aortic Dissection.

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Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 70 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing one lung ventilation during thoracic surgical procedures

Inclusion criteria

  • Patients undergoing one lung ventilation

Exclusion criteria

Exclusion Criteria:

  • No exclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
690 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Postoperative pulmonary complications

    Atelectasis, acute respiratory failure, ARDS, pneumonia, reintubation, empyema, bronchospasm, pneumothorax, pneumonitis, bronchopleural fistula

    Time frame: Postoperative. One week

Secondary outcomes

  1. Descriptive analysis of the open lung PEEP

    Open lung PEEP is the PEEP of best dynamic respiratory system compliance during a PEEP titration trial

    Time frame: intraoperative

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03184974
Lead sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Responsible party
Carlos Ferrando (Principal investigador, Fundación para la Investigación del Hospital Clínico de Valencia) — Principal investigator
First posted
Jun 14, 2017
Start date
Oct 1, 2015
Primary completion
Oct 1, 2016
Completion
Nov 1, 2016
Last update
Mar 7, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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