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OpenTrials
Completed

NCT Number: NCT02798133

Open Lung Approach Versus Standard Protective Strategies

The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low tidal volume (VT) ventilation, with or without an individualized post-RM positive end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status I-III undergoing elective major abdominal surgery including pancreatic-duodenectomy, gastrectomy and liver resection

Exclusion criteria

  • i) laparoscopic surgery, ii) patients with previous respiratory disease.

Treatment and study plan

OLA

Procedure

PEEP titration trial for best Cdyn after the alveolar recruitment maneuver

RM-5

Procedure

Fixed standard PEEP after the alveolar recruitment maneuver

Primary outcomes

  1. driving pressure

    Time frame: intraoperative

    The driving pressure is a physiological ventilatory parameter measured as platteau pressure minus PEEP. This parameter may be associated with postoperative pulmonary complications

Secondary outcomes

  1. ventilatory efficiency

    Time frame: intraoperative

    Ventilatory efficiency measured with volumetric capnography which includes dead space and tidal elimination of carbon dioxide.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study title

Open Lung Approach Versus Standard Protective Strategies: Effects on Driving Pressure and Ventilatory Efficiency During Anesthesia

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 14, 2016
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.