Comparison of Different Ventilation Mode During One-lung Ventilation

Thoracic Surgery Clinical Trial

Official title:

Comparison of Pressure-controlled Ventilation With Volume-controlled Ventilation During One-lung Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03061617
• Other study ID #: B2012-064
• Status: Completed
• Phase: N/A
• First received: February 6, 2017
• Last updated: February 21, 2017
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is controversial as to which ventilation mode is better in one-lung ventilation(OLV), volume controlled ventilation(VCV) or pressure controlled ventilation(PCV). This study was designed to figure out if there was any difference between these two modes on oxygenation and postoperative complications under the condition of protective ventilation(PV).

Description:

This is a single center, single blinded prospective study on two different ventilation mode during one lung ventilation for patients under video assistant thoracoscopy(VATS) lobectomy. After institutional approval and written informed consent were obtained, 60 patients with primary lung cancer under VATS lobectomy in Zhongshan Hospital Fudan University were enrolled and randomized into two groups:VCV group(group V) or PCV group(group P).

Inclusion criteria were age between 18-75 years , ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1>50% predicted. Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1>50% predicted

Exclusion Criteria:

• Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs

Related Conditions & MeSH terms

• Lung Injury
• One Lung Ventilation
• Thoracic Surgery
• Ventilator-Induced Lung Injury

Intervention

Other:
• VCV mode
set fixed 6ml/kg tide volume
• PCV mode
adjust pressure to achieve tide volume of 6ml/kg

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Lin F, Pan L, Qian W, Ge W, Dai H, Liang Y. Comparison of three ventilatory modes during one-lung ventilation in elderly patients. Int J Clin Exp Med. 2015 Jun 15;8(6):9955-60. — View Citation

Song SY, Jung JY, Cho MS, Kim JH, Ryu TH, Kim BI. Volume-controlled versus pressure-controlled ventilation-volume guaranteed mode during one-lung ventilation. Korean J Anesthesiol. 2014 Oct;67(4):258-63. doi: 10.4097/kjae.2014.67.4.258. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway pressure Ppeak	Airway pressure Ppeak in cmH2O.	during procedure
Primary	Airway pressure Pplat	Airway pressure Pplat in cmH2O.	during procedure
Primary	oxygenation index	Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is measured by gas monitor.	during procedure
Primary	oxygenation index	Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is calculated by [21+4×oxygen flow(L/min)]×100%.	surgery
Secondary	postoperative complications	including air leak, pneumonia, bronchopleural fistula, respiratory failure, ARDS, reintubation, tracheostomy, pulmonary embolism, arrhythmia requiring treatment, myocardial infarction, renal dysfunction, central neurologic event, sepsis, unexpected return to operating room, unexpected ICU admission and mortality within 30 days	within 30 days after surgery