Driving Pressure Limited Ventilation During Video-assisted Thoracoscopic Lobectomy

NCT03177564 | Unknown DMC

• 1 other identifier: XYFY-2017-033
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Complication; Thoracic Surgery

Keywords

driving pressure; one-lung ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• respiratory compliance

  during surgery

• TNF-α

  the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation

• IL-8

  the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation

• ICU mortality

  Patients will be followed during the period of hospital stay, an expected average of 28 days

Study Arms (3)

Protective Ventilation 1

ACTIVE COMPARATOR

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%.

Procedure: Protective ventilation 1

Protective Ventilation 2

ACTIVE COMPARATOR

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.

Procedure: Protective ventilation 2

Driving Pressure Limited Ventilation

EXPERIMENTAL

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

Procedure: Driving Pressure Limited Ventilation

Interventions

Protective ventilation 1 PROCEDURE

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

Protective Ventilation 1

Protective ventilation 2 PROCEDURE

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

Protective Ventilation 2

Driving Pressure Limited Ventilation 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%

Driving Pressure Limited Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults greater than or equal to 18 years
• ARISCAT（Assess Respiratory Risk in Surgical Patients in Catalonia）≥26 points
• Patients undergoing video-assisted thoracoscopic lobectomy

You may not qualify if:

• The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
• Emergency surgery
• Pulmonary hypertension
• Forced vital capacity or forced expiratory volume in 1 sec \< 70% of the predicted values
• Coagulation disorder
• Pulmonary or extrapulmonary infections
• History of treatment with steroid in 3 months before surgery
• History of recurrent pneumothorax
• History of lung resection surgery
• History of mechanical ventilation in 2 weeks
• Body Mass Index\[≥35 kg／m2 \]
• Patient who is contraindicated with application of positive end expiratory pressure

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 26947624 RESULT

• 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.

  PMID: 24901240 RESULT

• 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.

  PMID: 20805178 RESULT

• 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.

  PMID: 26304285 RESULT

• 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.

  PMID: 27894328 RESULT

• 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.

  PMID: 25693019 RESULT

• 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.

  PMID: 28159013 RESULT

• 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.

  PMID: 27875410 RESULT

Central Study Contacts

Liu gongjian, M.D/Ph.D

CONTACT

+86-13952203528; liugongjian61@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2017
• First Posted: June 6, 2017
• Study Start: June 5, 2017
• Primary Completion: June 10, 2018
• Study Completion: June 10, 2018
• Last Updated: June 6, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)