Clinical trial NCT04519606: Respiratory Mechanics During One-lung Ventilation
Official title: Optimization of Respiratory Mechanics During One-lung Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator-Induced Lung Injury
Lung Ventilator
One-lung Ventilation
Keywords: Barotrauma
Volutrauma
Biotrauma
Atelectasis
Lung recruitment
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Generally healthy (ASA PC I-III) patients receiving thoracic surgery that required intraoperative OLV

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Optimal level of lung compliance during OLV
timeFrame: During the OLV phase of thoracic surgery
Secondary outcomes:
measure: Postoperative pulmonary complication
timeFrame: 3 days after operation
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-DA hospital
Study officials:
References: