Driving Pressure Limited Ventilation During Video-assisted Thoracoscopic Lobectomy

NCT ID: NCT03177564

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-05
• Study Completion Date: 2018-06-10

Brief 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.

Detailed 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.

Conditions

Pulmonary Complication; Thoracic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Protective Ventilation 1

Intraoperatively ventilated patients with a tidal volume (VT) of 10 ml/kg of ideal body weight, the level of PEEP at 0 cmH2O and a FiO2 of100%.

Group Type: ACTIVE_COMPARATOR

Protective ventilation 1

Intervention Type: PROCEDURE

Low tidal volume, high inspired oygen fraction (FiO2) and recruitment maneuver.

Protective Ventilation 2

Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 5cmH2O and a FiO2 of 60% with lung recruitment maneuvers.

Group Type: ACTIVE_COMPARATOR

Protective ventilation 2

Intervention Type: PROCEDURE

Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.

Driving Pressure Limited Ventilation

The intervention arm receives driving pressure limited ventilation during one-lung ventilation

Group Type: EXPERIMENTAL

Driving Pressure Limited Ventilation

Intervention Type: PROCEDURE

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%

Interventions

Protective ventilation 1

Low tidal volume, high inspired oygen fraction (FiO2) and recruitment maneuver.

Intervention Type: PROCEDURE

Protective ventilation 2

Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.

Intervention Type: PROCEDURE

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%

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liu gongjian, M.D/Ph.D

Role: CONTACT

liugongjian61@hotmail.com

+86-13952203528

Facility Contacts

Liu gongjian, M.D/Ph.D

Role: primary

liugongjian61@hotmail.com

+86-13952203528

References

Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay 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, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.

Reference Type: RESULT

PMID: 26947624 (View on PubMed)

Mazo V, Sabate 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.0000000000000334.

Reference Type: RESULT

PMID: 24901240 (View on PubMed)

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.2009.123083.

Reference Type: RESULT

PMID: 20805178 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26304285 (View on PubMed)

Guerin 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. Crit Care. 2016 Nov 29;20(1):384. doi: 10.1186/s13054-016-1556-2.

Reference Type: RESULT

PMID: 27894328 (View on PubMed)

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. No abstract available.

Reference Type: RESULT

PMID: 25693019 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28159013 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27875410 (View on PubMed)

Other Identifiers

XYFY-2017-033

Identifier Type: -

Identifier Source: org_study_id