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

Effect of Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume on Oxygenation and Outcome: Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Hypoxemia; ARDS, Human; Pulmonary Sepsis
• Intervention / Treatment: Other: change of ventilatory settings

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Debrecen, Hungary, 4032
    • University of Debrecen, Department of anesthesiology and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative oxygenation	PaO2 < 60 mmHg	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Debrecen

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (ACTUAL): December 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Hypoxia; Respiratory Distress Syndrome
• Other Study ID Numbers: DE RKEB/IKEB 4737-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No