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

Sponsor
University of Debrecen (Other)
Overall Status
Completed
CT.gov ID
NCT03364465
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
13.9
Actual Duration (Months)
10.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: change of ventilatory settings
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Effect of Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume on Oxygenation and Outcome: Randomized, Controlled Trial
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
No Intervention: GruopFix

one-lung ventilation with constant tidal volume
Active Comparator: GroupVariable

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

Other: change of ventilatory settings
change of tidal volume during one-lung ventilation

Outcome Measures

Primary Outcome Measures

  1. intraoperative oxygenation [1 day]

    PaO2 < 60 mmHg

Secondary Outcome Measures

  1. postoperative pulmonary complications [90 days]

    infiltrate on chest X-ray, fever, laboratory and physical signs of infection

  2. postoperative extra-pulmonary complications [90 days]

    new atrial fibrillation

  3. 30-day survival/mortality [30 days]

    number of death within 30 days after surgery

  4. 90-day survival/mortality [90 days]

    number of death death within 90 days after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Debrecen, Department of Anesthesiology and Intensive Care Debrecen Hungary 4032

Sponsors and Collaborators

  • University of Debrecen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tamas Vegh, MD, Head, Division of General, Vascular and Thoracic Anesthesia, University of Debrecen
ClinicalTrials.gov Identifier:
NCT03364465
Other Study ID Numbers:
  • DE RKEB/IKEB 4737-2017
First Posted:
Dec 6, 2017
Last Update Posted:
Apr 16, 2019
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Distress Syndrome
Hypoxia

Study Results

No Results Posted as of Apr 16, 2019