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Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume

Primary Purpose

Hypoxemia, Pulmonary Sepsis, ARDS, Human

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
change of ventilatory settings
Sponsored by
University of Debrecen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
  • BMI < 35 kg/m2
  • Age ≥ 18 years
  • Expected duration of surgery > 60 min
  • Expected duration of anesthesia > 90 min

Exclusion Criteria:

  • COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax
  • uncontrolled asthma
  • NYHA 3+4, CCS 3+4
  • previous thoracic surgery
  • ARDS (Berlin definition)
  • documented pulmonary arterial hypertension > 40 mmHg syst
  • documented or suspected neuromuscular disease (thymoma, myasthenia)
  • planned mechanical ventilation after surgery
  • bilateral procedures
  • lung separation with other method than DLT (eg diff. airway, tracheostomy)
  • surgery in prone position
  • persistent hemodynamic instability, intractable shock
  • intracranial injury or tumor
  • enrollment in other interventional study or refusal of informed consent
  • pregnancy (excluded by anamnesis and/or laboratory analysis)

Sites / Locations

  • University of Debrecen, Department of Anesthesiology and Intensive Care

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

GruopFix

GroupVariable

Arm Description

one-lung ventilation with constant tidal volume

one-lung ventilation with variable tidal volume Intervention: change of ventilatory settings

Outcomes

Primary Outcome Measures

intraoperative oxygenation
PaO2 < 60 mmHg

Secondary Outcome Measures

postoperative pulmonary complications
infiltrate on chest X-ray, fever, laboratory and physical signs of infection
postoperative extra-pulmonary complications
new atrial fibrillation
30-day survival/mortality
number of death within 30 days after surgery
90-day survival/mortality
number of death death within 90 days after surgery

Full Information

First Posted
November 22, 2017
Last Updated
April 15, 2019
Sponsor
University of Debrecen
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1. Study Identification

Unique Protocol Identification Number
NCT03364465
Brief Title
Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume
Official Title
Effect of Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume on Oxygenation and Outcome: Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Debrecen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis. Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable low tidal volume for intraoperative oxygenation and protection against PPCs. Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable tidal volume with recruitment maneuvers during thoracic surgery in adults. We hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable tidal volumes, modearte PEEP and recruitment maneuvers as compared to constant without recruitment maneuvers prevent PPCs. Patients will be randomly assigned to one of two groups: FIX TIDAL VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers VARIABLE TIDAL VOLUME GROUP (Groupvar): mechanical ventilation with variable (6 ml/kgIBW ± 33%) tidal volume with variable respiratory rate to maintain constant minute ventilation and PEEP of 5 cmH2O with recruitment maneuvers.
Detailed Description
Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP. In GroupVar VT will be 6 ml/kg predicted body weight ±33% with 5 cmH2O PEEP. Respiratory rate will be adjusted to maintain same minute ventilation as during two-lung ventilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia, Pulmonary Sepsis, ARDS, Human, Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GruopFix
Arm Type
No Intervention
Arm Description
one-lung ventilation with constant tidal volume
Arm Title
GroupVariable
Arm Type
Active Comparator
Arm Description
one-lung ventilation with variable tidal volume Intervention: change of ventilatory settings
Intervention Type
Other
Intervention Name(s)
change of ventilatory settings
Intervention Description
change of tidal volume during one-lung ventilation
Primary Outcome Measure Information:
Title
intraoperative oxygenation
Description
PaO2 < 60 mmHg
Time Frame
1 day
Secondary Outcome Measure Information:
Title
postoperative pulmonary complications
Description
infiltrate on chest X-ray, fever, laboratory and physical signs of infection
Time Frame
90 days
Title
postoperative extra-pulmonary complications
Description
new atrial fibrillation
Time Frame
90 days
Title
30-day survival/mortality
Description
number of death within 30 days after surgery
Time Frame
30 days
Title
90-day survival/mortality
Description
number of death death within 90 days after surgery
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery) BMI < 35 kg/m2 Age ≥ 18 years Expected duration of surgery > 60 min Expected duration of anesthesia > 90 min Exclusion Criteria: COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax uncontrolled asthma NYHA 3+4, CCS 3+4 previous thoracic surgery ARDS (Berlin definition) documented pulmonary arterial hypertension > 40 mmHg syst documented or suspected neuromuscular disease (thymoma, myasthenia) planned mechanical ventilation after surgery bilateral procedures lung separation with other method than DLT (eg diff. airway, tracheostomy) surgery in prone position persistent hemodynamic instability, intractable shock intracranial injury or tumor enrollment in other interventional study or refusal of informed consent pregnancy (excluded by anamnesis and/or laboratory analysis)
Facility Information:
Facility Name
University of Debrecen, Department of Anesthesiology and Intensive Care
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

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Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume

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