NCT03728010

Brief Summary

Mechanical ventilation can cause damage to the lung parenchyma, this is known as ventilatory induce lung injury (VILI).To avoid this damage, ventilatory strategies have been created, focused on the reduction of tidal volume, airway pressures and use of PEEP (positive end-expiratory pressure), which together are called "protective ventilation". Although ventilation with protective parameters seems to reduce VILI in one-lung ventilation, the optimal parameters are not clear.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 9, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

5.1 years

First QC Date

October 9, 2018

Last Update Submit

May 10, 2023

Conditions

Ventilator Lung

Keywords

Electrical impedance tomographyOne-lung ventilationProtective ventilationVentilator- Induce Lung injury

Outcome Measures

Primary Outcomes (3)

  • Ventilation/ perfusion ratio

    Electrical impedance tomography.

    1 hour

  • Pulmonary mechanics

    Airway pressure ,esophageal pressure measurement.

    1 hour

  • Arterial gas measurement

    5 samples per patient

    20 minutes

Study Arms (1)

One-Lung Ventilarion

Thoracic surgery cases with one-lung ventilation strategy.

Diagnostic Test: Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurement

Interventions

Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurementDIAGNOSTIC_TEST

After general anesthesia, patients will be ventilated with three tidal volume level (4, 6 and 8 cc / Kg / IBW), in two levels of PEEP, 6 cm2 H20, and best PEEP, the latter obtained after a recruitment maneuver and decremental titration.

One-Lung Ventilarion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients between 18 and 75 years old. With pulmonary diseases that require thoracic surgery with one-lung ventilation.

You may qualify if:

  • ASA (American Society of Anesthesiologists) classification I-III
  • Age 18-75 Years
  • Elective thoracic surgery
  • One-Lung Ventilation
  • Healthy non ventilated lung

You may not qualify if:

  • ASA classification \> III
  • BMI (Body mass index) \> 30
  • Emergency surgery
  • Pregnancy
  • Patients includes in other protocols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chile Clinical Hospital

Santiago, 562, Chile

RECRUITING

Related Publications (5)

  • Gattinoni L, Protti A, Caironi P, Carlesso E. Ventilator-induced lung injury: the anatomical and physiological framework. Crit Care Med. 2010 Oct;38(10 Suppl):S539-48. doi: 10.1097/CCM.0b013e3181f1fcf7.

    PMID: 21164395BACKGROUND

  • Pinhu L, Whitehead T, Evans T, Griffiths M. Ventilator-associated lung injury. Lancet. 2003 Jan 25;361(9354):332-40. doi: 10.1016/S0140-6736(03)12329-X.

    PMID: 12559881BACKGROUND

  • Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.

    PMID: 10793162BACKGROUND

  • Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

    PMID: 23902482BACKGROUND

  • El Tahan MR, Pasin L, Marczin N, Landoni G. Impact of Low Tidal Volumes During One-Lung Ventilation. A Meta-Analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2017 Oct;31(5):1767-1773. doi: 10.1053/j.jvca.2017.06.015. Epub 2017 Jun 7.

    PMID: 28843606BACKGROUND

Central Study Contacts

Roberto Gonzalez, MD

CONTACT

56999397515robgonzalez@uchile.cl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

October 9, 2018

First Posted

November 1, 2018

Study Start

December 7, 2018

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)