Respiratory Mechanics During One-lung Ventilation

NCT04519606 | Completed

• 1 other identifier: EMRP69108N
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative lung protective ventilatory strategy has been widely recognized to reduce postoperative pulmonary complications in laparotomy and laparoscopic surgeries. However, the clinical evidence and consensus for ventilatory strategy to protect the dependent lung segments during thoracic surgery that requires one-lung ventilation (OLV) is currently not available. Since lung compliance changes significantly during OLV, the levels of respiratory mechanics should be optimized to avoid barotrauma and volutrauma. This study aims to determine the optimal levels of volume-pressure dynamics during OLV and at the phase of recruitment of the independent lungs by achieving optimal lung compliance, gas exchange and hemodynamics.

Conditions

Ventilator-Induced Lung Injury; Lung Ventilator; One-lung Ventilation

Keywords

Barotrauma; Volutrauma; Biotrauma; Atelectasis; Lung recruitment

Outcome Measures

Primary Outcomes (1)

• Optimal level of lung compliance during OLV

  A tidal volume (4-7 ml/kg PBW) where the pressure-volume loop reaches upper refection point and the peak airway pressure at or just below 30 cmH2O

  During the OLV phase of thoracic surgery

Secondary Outcomes (1)

• Postoperative pulmonary complication

  3 days after operation

Study Arms (1)

One-lung ventilation

During one-lung ventilation, the dependent lung (non-operation lung) will be mechanically ventilated with a fixed positive end-expiratory pressure (PEEP) of 4 cmH2O and the peak pressure below 30 cmH2O. Tidal volumes will be titrated from the initial 4 ml/kg predicted body weight (PBW) to 7 ml/kg PBW. Optimal lung compliance is determined by the levels of upper reflection point of the pressure-volume loop closed to 30 cmH2O. Chest tomography will be undertaken with the optimal tidal volume during OLV phase and when the independent lung is completely recruited using the stepwise PEEP increase method.

Procedure: Optimal lung compliance during OLV

Interventions

Optimal lung compliance during OLV PROCEDURE

Stepwise increase of tidal volume from 4 ml/kg PBW to 7 ml/kg PBW during OLV to determine the optimal tidal volume at the level the the pressure-volume loop reaches upper refection point where the peak airway pressure at or just below 30 cmH2O

One-lung ventilation

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Generally healthy (ASA PC I-III) patients receiving thoracic surgery that required intraoperative OLV

You may qualify if:

• Scheduled for single lobectomy or wedge resection of right or left lung lobe
• American Society of Anesthesiologists physical classification (ASA PC) I-III
• Preoperative normal pulmonary function test

You may not qualify if:

• Anticipated difficult intubation or ventilation
• Severe heart failure (NYHA Fc \>=3)
• Advanced liver cirrhosis (Child-Pugh score \>=B)
• Advanced renal disease (creatinine \>2 mg/dl)
• Severe anemia (hemoglobin \<8 mg/dl)
• Body mass index \>30
• Pregnancy
• Emergency operation
• Prior history of heart, lung or mediastinal surgery
• Psychiatric or other mental disorders
• Patient refusal

Sponsors & Collaborators

• E-DA Hospital: lead

Study Sites (1)

E-DA hospital

Kaohsiung City, 824, Taiwan

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Barotrauma; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Superintendent, professor

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 19, 2020
• Study Start: December 1, 2020
• Primary Completion: August 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-10

Locations

TW (1)