NCT03056885

Brief Summary

This study evaluates the local cytokine inflammatory response during one lung ventilation in patients undergoing pulmonary lobectomy or wedge resection. We compare two different ventilation strategies: a conventional strategy with a protective strategy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2015

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

23 days

First QC Date

February 12, 2017

Last Update Submit

February 14, 2017

Conditions

Ventilator-Induced Lung InjuryInflammatory ResponseRespiratory Complication

Keywords

one-lung ventilationbroncho-alveolar lavageprotective ventilationcytokinesthoracic surgery

Outcome Measures

Primary Outcomes (1)

  • local cytokine inflammatory response in the two study groups

    The levels of cytokines were evaluated in broncho-alveolar lavage (BAL)

    Change from Baseline cytokines level and the end of surgery (about 60 minutes)

Secondary Outcomes (2)

  • incidence of postoperative respiratory in the two study groups

    within 48 hours of the operation

  • lenght of stay in the two study groups

    1 month

Study Arms (2)

Conventional One-lung ventilation

EXPERIMENTAL

The patients received a Tidal volume of 10 ml/kg (based on Predicted body weight)

Other: Conventional One-Lung Ventilation

Protective One-Lung Ventilation

EXPERIMENTAL

The patients received a Tidal volume of 5 ml/kg (based on Predicted body weight)

Other: Protective One-lung ventilation

Interventions

Conventional One-Lung VentilationOTHER

Vt 10 ml/kg

Conventional One-lung ventilation
Protective One-lung ventilationOTHER

Vt 5 ml/kg

Protective One-Lung Ventilation

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing elective lobectomy and wedge resection

You may not qualify if:

  • emergency surgery, pregnancy, patient refusal, inability to give consent, age ≤ 18 years and ≥ ASA IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

February 12, 2017

First Posted

February 17, 2017

Study Start

November 2, 2015

Primary Completion

November 25, 2015

Study Completion

January 15, 2016

Last Updated

February 17, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share