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

NCT03364465 | Completed

• 1 other identifier: DE RKEB/IKEB 4737-2017
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia; Pulmonary Sepsis; ARDS, Human; Pneumonia

Outcome Measures

Primary Outcomes (1)

• intraoperative oxygenation

  PaO2 \< 60 mmHg

  1 day

Secondary Outcomes (4)

• postoperative pulmonary complications

  90 days

• postoperative extra-pulmonary complications

  90 days

• 30-day survival/mortality

  30 days

• 90-day survival/mortality

  90 days

Study Arms (2)

GruopFix

NO INTERVENTION

one-lung ventilation with constant tidal volume

GroupVariable

ACTIVE COMPARATOR

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

Other: change of ventilatory settings

Interventions

change of ventilatory settings OTHER

change of tidal volume during one-lung ventilation

GroupVariable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Debrecen: lead

Study Sites (1)

University of Debrecen, Department of Anesthesiology and Intensive Care

Debrecen, 4032, Hungary

Location

Related Publications (1)

• Szamos K, Balla B, Paloczi B, Enyedi A, Sessler DI, Fulesdi B, Vegh T. One-lung ventilation with fixed and variable tidal volumes on oxygenation and pulmonary outcomes: A randomized trial. J Clin Anesth. 2024 Aug;95:111465. doi: 10.1016/j.jclinane.2024.111465. Epub 2024 Apr 6.

  PMID: 38581926 DERIVED

MeSH Terms

Conditions

Hypoxia; Respiratory Distress Syndrome; Pneumonia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Tract Infections; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Division of General, Vascular and Thoracic Anesthesia

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 6, 2017
• Study Start: February 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)