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NCT Number: NCT03794414

Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation

The present study is to evaluate the effect of positive end-expiratory pressure (PEEP) in predicting fluid responsiveness in patients undergoing one-lung ventilation.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangnam Sungshim Hospital

Seoul, South Korea

About this study

Appropriate fluid challenge is crucial during lung surgery under one-lung ventilation. Applying PEEP in mechanically ventilating patients changes dynamic hemodynamic parameters (stroke volume variation, pulse pressure variation), which is more pronounced in hypovolemic patients. The aim of the present study is to evaluate the mechanically ventilating patients under one-lung ventilation requiring fluid resuscitation by applying PEEP to predict fluid responsiveness.

The investigators hypothesized that applying PEEP in one-lung ventilating patients can also change dynamic parameters and the magnitude of the change of stroke volume variation, pulse pressure variation can predict fluid responsiveness. The investigator applied PEEP 10 mmHg in one-lung ventilating patients and observed the dynamic parameters including stroke volume variation, pulse pressure variation and then infused 6ml/kg of crystalloid for fluid challenge and diagnosed fluid responsiveness as 10% increase of stroke volume after fluid challenge.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing lung surgery under one-lung ventilation

Exclusion criteria

  • arrhythmia
  • moderate to severe valvular heart disease moderate to severe pericardial effusion left ventricular ejection fraction < 40%
  • moderate to severe chronic obstructive lung disease
  • unable to insert oesophageal Doppler Monitor (ODM) probe ( esophageal stent, esophageal cancer, previous esophageal surgery, esophageal stricture, esophageal varices, pharyngeal pouch and severe coagulopathy )
  • patient refusal
  • cannot understand the protocol
  • less than 50kg or over 100kg in weight

Treatment and study plan

PEEP challenge

Procedure

apply PEEP 10 mmHg in one-lung ventilating patients.

Primary outcomes

  1. pulse pressure variation

    Time frame: 5 minutes after PEEP challenge

    Temporary increase of PEEP will be able to predict fluid responsiveness using increase of pulse pressure variation over 1%.

Secondary outcomes

  1. stroke volume variation

    Time frame: 5 minutes after PEEP challenge

    Temporary increase of PEEP will be able to predict fluid responsiveness using increase of stroke volume variation over 1%.

Sponsors and collaborators

Lead sponsor

Hallym University Kangnam Sacred Heart Hospital

Other

Registry information

Official study title

The Influence of Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 7, 2019
Registry last updated
Jul 29, 2020

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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