NCT03794414

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

January 31, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

January 3, 2019

Last Update Submit

July 26, 2020

Conditions

Lung CancerLung Diseases

Outcome Measures

Primary Outcomes (1)

  • pulse pressure variation

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

    5 minutes after PEEP challenge

Secondary Outcomes (1)

  • stroke volume variation

    5 minutes after PEEP challenge

Study Arms (2)

fluid responder

EXPERIMENTAL

patients with 10% or more increase in stroke volume after fluid challenge. Both arms receive PEEP challenge.

Procedure: PEEP challenge

fluid non-responder

EXPERIMENTAL

patients with no increase or less than 10% increase in stroke volume after fluid challenge. Both arms receive PEEP challenge

Procedure: PEEP challenge

Interventions

PEEP challengePROCEDURE

apply PEEP 10 mmHg in one-lung ventilating patients.

fluid non-responderfluid responder

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing lung surgery under one-lung ventilation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangnam Sungshim Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Lung NeoplasmsLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract Diseases

Study Officials

  • Eun-mi Choi, Professor

    Kangnam Sungshim Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 7, 2019

Study Start

January 31, 2019

Primary Completion

June 26, 2020

Study Completion

June 26, 2020

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

However, I can always share if required.

Locations

KR(1)