NCT00534690

Brief Summary

During general anesthesia, airway closure and the formation of atelectasis impair oxygenation. During one-lung ventilation, large tidal volumes are used to resume atelectasis with a risk of regional over distension and Ventilator-Induced Lung Injury (VILI). The reduction in TV should reduce the occurrence of VILI but lead to a consistent alveolar derecruitment. This harmful effect may be counteracted by PEP. We, therefore, study the impact on oxygenation, of increasing PEP during OLV, in order to maintain alveolar recruitment when TV is reduced.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

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

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 21, 2010

Status Verified

January 1, 2010

Enrollment Period

1.2 years

First QC Date

September 24, 2007

Last Update Submit

January 20, 2010

Conditions

Lung NeoplasmsPulmonary Disease

Keywords

Pulmonary diseaseIntubation, IntratrachealPositive-pressure ventilation

Outcome Measures

Primary Outcomes (1)

  • PaO2/FiO2 after 10 minutes of each strategy

    15 minutes after selective intubation and 10 minutes after the beginning of each ventilation type.

Secondary Outcomes (2)

  • Occurrence of intrinsic PEP.

    Peroperative period

  • Haemodynamic side effects: decrease of more than 20% of the arterial systolic blood pressure

    peroperative period

Study Arms (2)

1

OTHER
Procedure: One-Lung ventilation

2

OTHER
Procedure: One-Llung ventilation

Interventions

One-Lung ventilationPROCEDURE

Low Vt, High PEP

1
One-Llung ventilationPROCEDURE

High Vt, low PEP

2

Eligibility Criteria

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

You may qualify if:

  • Age\> 18 years
  • Open-chest thoracotomy for pulmonary resection
  • oral consent

You may not qualify if:

  • Severe obstructive disease (FEV1 or FEV1 /CV \< 70%)
  • Patient who don't tolerate a one-lung ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux

Pessac, 33604, France

Location

Related Publications (6)

  • Fernandez-Perez ER, Keegan MT, Brown DR, Hubmayr RD, Gajic O. Intraoperative tidal volume as a risk factor for respiratory failure after pneumonectomy. Anesthesiology. 2006 Jul;105(1):14-8. doi: 10.1097/00000542-200607000-00007.

    PMID: 16809989BACKGROUND

  • Gothard J. Lung injury after thoracic surgery and one-lung ventilation. Curr Opin Anaesthesiol. 2006 Feb;19(1):5-10. doi: 10.1097/01.aco.0000192783.40021.c1.

    PMID: 16547427BACKGROUND

  • Slinger P. Pro: low tidal volume is indicated during one-lung ventilation. Anesth Analg. 2006 Aug;103(2):268-70. doi: 10.1213/01.ane.0000223701.24874.c8. No abstract available.

    PMID: 16861400BACKGROUND

  • Senturk M. New concepts of the management of one-lung ventilation. Curr Opin Anaesthesiol. 2006 Feb;19(1):1-4. doi: 10.1097/01.aco.0000192778.17151.2c.

    PMID: 16547426BACKGROUND

  • Schultz MJ, Haitsma JJ, Slutsky AS, Gajic O. What tidal volumes should be used in patients without acute lung injury? Anesthesiology. 2007 Jun;106(6):1226-31. doi: 10.1097/01.anes.0000267607.25011.e8.

    PMID: 17525599BACKGROUND

  • Michelet P, D'Journo XB, Roch A, Doddoli C, Marin V, Papazian L, Decamps I, Bregeon F, Thomas P, Auffray JP. Protective ventilation influences systemic inflammation after esophagectomy: a randomized controlled study. Anesthesiology. 2006 Nov;105(5):911-9. doi: 10.1097/00000542-200611000-00011.

    PMID: 17065884BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsLung Diseases

Interventions

One-Lung Ventilation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeutics

Study Officials

  • Hadrien ROZE, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Paul PEREZ, Dr

    University Hospital (USMR), Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

November 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 21, 2010

Record last verified: 2010-01

Locations

FR(1)