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Completed

NCT Number: NCT01630395

The Effect of Recruitment Maneuver With Protective Ventilation During Thoracic Surgery

The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20 Years and older
  • Patients undergoing thoracic surgery

Exclusion criteria

  • Emergency surgery
  • Heart failure
  • Pulmonary hypertension
  • Forced vital capacity or forced expiratory volume in 1 sec < 50% of the predicted values
  • Coagulation disorder
  • Pulmonary or extrapulmonary infections
  • History of treatment with steroid in 3 months before surgery
  • History of recurrent pneumothorax
  • History of lung resection surgery

Treatment and study plan

protective ventilation

Procedure

low tidal volume and PEEP

Recruitment maneuver combined with protective ventilation

Procedure

Low tidal volume, PEEP and recruitment maneuver

Primary outcomes

  1. Levels of IL-8, TNFa in the bronchoalveolar lavage

    Time frame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery

Secondary outcomes

  1. Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage

    Time frame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery

  2. plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa

    Time frame: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery

  3. oxygenation

    Time frame: 1 hour after extubation

    Changes in PaO2/FIO2 ratio

  4. Chest-X ray

    Time frame: 7 days after surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2012
Registry last updated
Apr 21, 2016

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.

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