Driving Pressure Limited Ventilation During Video-assisted Thoracoscopic Lobectomy

Thoracic Surgery Clinical Trial

Official title:

A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy During Video-assisted Thoracoscopic Lobectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03177564
• Other study ID #: XYFY-2017-033
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2017
• Last updated: June 5, 2017
• Start date: June 5, 2017
• Est. completion date: June 10, 2018

Study information

• Verified date: June 2017
• Source: The Affiliated Hospital of Xuzhou Medical University
• Contact: Liu gongjian, M.D/Ph.D
• Phone: +86-13952203528
• Email: liugongjian61[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients undergoing one-lung ventilation during Video-assisted thoracoscopic lobectomy.

Description:

• More recently, the so-called lung-protective intraoperative ventilation strategies have been advocated to prevent lung injury. Such strategies aim at minimizing lung hyperinflation as well as cycling collapse and reopening of lung units, through the use of low tidal volumes (VTs) and positive end-expiratory pressure (PEEP). However, despite huge improvements in surgical and anesthesia techniques and management. It is surprising that, so far, mortality and pulmonary complication rates were not reduced over time .Recently, several investigations suggest an association between high driving pressure (the difference between the plateau pressure and the level of PEEP) and outcome for patients with acute respiratory distress syndrome. It is uncertain whether a similar association exists for high driving pressure during surgery and the occurrence of postoperative pulmonary complications. In this issue, Ary S Neto and colleagues report an individual patient data meta-analysis further investigating the risk of mechanical ventilation in healthy individuals during general anesthesia .After both a multivariate and mediation analysis, the driving pressure, but not the tidal volume or the positive end-expiratory pressure applied, seemed to be the only parameter that was associated with the development of postoperative pulmonary complications. This randomized controlled trial is aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 10, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults greater than or equal to 18 years

2. ARISCAT(Assess Respiratory Risk in Surgical Patients in Catalonia)=26 points

3. Patients undergoing video-assisted thoracoscopic lobectomy

Exclusion Criteria:

1. The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4

2. Emergency surgery

3. Pulmonary hypertension

4. Forced vital capacity or forced expiratory volume in 1 sec < 70% of the predicted values

5. Coagulation disorder

6. Pulmonary or extrapulmonary infections

7. History of treatment with steroid in 3 months before surgery

8. History of recurrent pneumothorax

9. History of lung resection surgery

10. History of mechanical ventilation in 2 weeks

11. Body Mass Index[=35 kg/m2 ]

12. Patient who is contraindicated with application of positive end expiratory pressure

Related Conditions & MeSH terms

• Pulmonary Complication
• Thoracic Surgery

Intervention

Procedure:
• Protective ventilation 1
Low tidal volume, high inspired oygen fraction (FiO2) and recruitment maneuver.
• Protective ventilation 2
Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
• Driving Pressure Limited Ventilation
Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 3 to 10 cmH2O during one-lung ventilation and a FiO2 of 60%

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

Agostini P, Cieslik H, Rathinam S, Bishay E, Kalkat MS, Rajesh PB, Steyn RS, Singh S, Naidu B. Postoperative pulmonary complications following thoracic surgery: are there any modifiable risk factors? Thorax. 2010 Sep;65(9):815-8. doi: 10.1136/thx.2009.123 — View Citation

Grieco DL, Chen L, Dres M, Brochard L. Should we use driving pressure to set tidal volume? Curr Opin Crit Care. 2017 Feb;23(1):38-44. doi: 10.1097/MCC.0000000000000377. — View Citation

Guérin C, Papazian L, Reignier J, Ayzac L, Loundou A, Forel JM; investigators of the Acurasys and Proseva trials. Effect of driving pressure on mortality in ARDS patients during lung protective mechanical ventilation in two randomized controlled trials. C — View Citation

Hager DN. Recent Advances in the Management of the Acute Respiratory Distress Syndrome. Clin Chest Med. 2015 Sep;36(3):481-96. doi: 10.1016/j.ccm.2015.05.002. Epub 2015 Jul 2. Review. — View Citation

Loring SH, Malhotra A. Driving pressure and respiratory mechanics in ARDS. N Engl J Med. 2015 Feb 19;372(8):776-7. doi: 10.1056/NEJMe1414218. — View Citation

Mazo V, Sabaté S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000 — View Citation

Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Günay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Sca — View Citation

Xie J, Jin F, Pan C, Liu S, Liu L, Xu J, Yang Y, Qiu H. The effects of low tidal ventilation on lung strain correlate with respiratory system compliance. Crit Care. 2017 Feb 3;21(1):23. doi: 10.1186/s13054-017-1600-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative pulmonary complications	Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale.	within the first 3 days after surgery
Secondary	Partial pressure of oxygen in arterial blood		15 min after induction, 20 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery
Secondary	respiratory compliance	Dynamic compliance, Static compliance	during surgery
Secondary	TNF-a		the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation
Secondary	IL-8		the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation
Secondary	ICU mortality		Patients will be followed during the period of hospital stay, an expected average of 28 days
Secondary	In-hospital mortality		Patients will be followed during the period of hospital stay, an expected average of 28 days
Secondary	28-day survival		From day 0 to day 28