Respiratory Mechanics During One-lung Ventilation

Ventilator-Induced Lung Injury Clinical Trial

Official title:

Optimization of Respiratory Mechanics During One-lung Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519606
• Other study ID #: EMRP69108N
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2021
• Source: E-DA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Background One-lung ventilation (OLV) is the foremost used technique of ventilation during thoracic procedures. Intraoperative lung separation can be managed by means of double-lumen endotracheal tube (DLT), bronchial blocker (BB), or nonintubated method. OLV is impeded by significant reduction in lung volume, decline in lung compliance at lateral decubital position, formation of intrapulmonary shunting and exposure of the dependent lung to ventilator-induced lung injury (VILI). In addition, patients receiving thoracic surgeries are more prone to developing acute lung injuries due to direct surgery-related trauma caused by instrumentation or manipulation of the lung tissues, hypoperfusion induced by hypoxic pulmonary vasoconstriction, and dysfunction of surfactant system. The non-dependent lung is injured by surgical manipulation and atelectrauma. Re-expansion of the collapsed non-dependent lung at the end of surgery inevitably results in systemic inflammatory response in the local and contralateral lungs, which in turn leads to biotrauma. Therefore, a significantly high pulmonary complication of up to 14-28.4% was reported in patients that received OLV surgery. In the recent two decades, there is a major paradigm shift for mechanical ventilator support during operation by the introduction of intraoperative lung protective ventilation strategies. Some of these changes include a low tidal volume (Vt), moderate levels of positive end-expiratory pressure (PEEP), optimal driving pressure (∆P) and the appropriate use of lung recruitment maneuver. Intraoperative lung protective ventilation strategies have been shown to reduce post-operative pulmonary complications and improve overall clinical outcomes in intermediate and high-risk patients undergoing major abdominal surgery. Currently, however, there is a lack of clinical evidence in regard to appropriate protective-lung strategies during OLV. The optimal levels of intraoperative use of oxygen fraction, the ventilatory settings for volume and pressure variables during OLV and re-expansion phases for lung recruitment are debating. The main objective of this clinical study is 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Optimal lung compliance during OLV
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

Locations

Country	Name	City	State
Taiwan	E-DA hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
E-DA Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative pulmonary complication	Composite endpoints of clinical diagnoses of pneumonia, bronchospasm, and/or ARDS), radiological diagnoses of atelectasis, pneumothorax, and/or pleural effusion, and therapies for respiratory insufficiency (need for prolonged therapy after end of surgery by providing supplemental oxygen, postoperative noninvasive ventilation, and/or reintubation with postoperative mechanical ventilation.	3 days after operation