ClinicalTrials.gov
ClinicalTrials.gov Menu

Driving Pressure Limited Ventilation During Video-assisted Thoracoscopic Lobectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03177564
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
The Affiliated Hospital of Xuzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Complication Thoracic Surgery Procedure: Protective ventilation 1 Procedure: Protective ventilation 2 Procedure: Driving Pressure Limited Ventilation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy During Video-assisted Thoracoscopic Lobectomy
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : June 10, 2018
Estimated Study Completion Date : June 10, 2018

Arm Intervention/treatment
Active Comparator: 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%.
Procedure: Protective ventilation 1
Low tidal volume, high inspired oygen fraction (FiO2) and recruitment maneuver.

Active Comparator: 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.
Procedure: Protective ventilation 2
Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.

Experimental: Driving Pressure Limited Ventilation
The intervention arm receives driving pressure limited ventilation during one-lung ventilation
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%




Primary Outcome Measures :
  1. The incidence of postoperative pulmonary complications [ Time Frame: within the first 3 days after surgery ]
    Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale.


Secondary Outcome Measures :
  1. Partial pressure of oxygen in arterial blood [ Time Frame: 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 ]
  2. respiratory compliance [ Time Frame: during surgery ]
    Dynamic compliance, Static compliance

  3. TNF-α [ Time Frame: the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation ]
  4. IL-8 [ Time Frame: the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation ]
  5. ICU mortality [ Time Frame: Patients will be followed during the period of hospital stay, an expected average of 28 days ]
  6. In-hospital mortality [ Time Frame: Patients will be followed during the period of hospital stay, an expected average of 28 days ]
  7. 28-day survival [ Time Frame: From day 0 to day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177564


Contacts
Contact: Liu gongjian, M.D/Ph.D +86-13952203528 liugongjian61@hotmail.com

Locations
China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Liu gongjian, M.D/Ph.D    +86-13952203528    liugongjian61@hotmail.com   
Sponsors and Collaborators
The Affiliated Hospital of Xuzhou Medical University

Publications of Results:
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, 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. Review. Erratum in: Lancet Respir Med. 2016 Jun;4(6):e34.

Responsible Party: The Affiliated Hospital of Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03177564     History of Changes
Other Study ID Numbers: XYFY-2017-033
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Affiliated Hospital of Xuzhou Medical University:
driving pressure
one-lung ventilation