Pulmonary ComplicationNCT03177564
Driving Pressure Limited Ventilation During Video-assisted Thoracoscopic Lobectomy
A study testing Protective ventilation 1, Protective ventilation 2 and Driving Pressure Limited Ventilation in people with Pulmonary Complication and Thoracic Surgery, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Complication, Thoracic Surgery
- What is being tested?
- Protective ventilation 1, Protective ventilation 2 and Driving Pressure Limited Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2017to 10 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Liu gongjian, M.D/Ph.D, +86-13952203528, liugongjian61@hotmail.com
About this study
Official title: A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy During Video-assisted Thoracoscopic Lobectomy
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.
Read the 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
- Being tested
- Protective ventilation 1, Protective ventilation 2, Driving Pressure Limited Ventilation
- Keywords
- driving pressure, one-lung ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective ventilation 1Procedure or surgery
Low tidal volume, high inspired oygen fraction (FiO2) and recruitment maneuver.
Protective ventilation 2Procedure or surgery
Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
Driving Pressure Limited VentilationProcedure or surgery
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%
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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. Receives: Procedure: Protective ventilation 2 |
| Driving Pressure Limited Ventilation | Experimental | The intervention arm receives driving pressure limited ventilation during one-lung ventilation Receives: Procedure: Driving Pressure Limited Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within the first 3 days after surgery
Secondary outcomes (7)
Partial pressure of oxygen in arterial blood
Measured: 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
Dynamic compliance, Static compliance
Measured: during surgery
TNF-α
Measured: the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation
IL-8
Measured: the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation
ICU mortality
Measured: Patients will be followed during the period of hospital stay, an expected average of 28 days
In-hospital mortality
Measured: Patients will be followed during the period of hospital stay, an expected average of 28 days
28-day survival
Measured: From day 0 to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start5 Jun 2017
- Primary completion10 Jun 2018 (estimated)
- Study completion10 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pulmonary ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177564
- Sponsor's protocol ID
- XYFY-2017-033
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26947624Mazo 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.
PubMed 24901240Agostini 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.
PubMed 20805178Hager 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.
PubMed 26304285Guerin 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.
PubMed 27894328Loring 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.
PubMed 25693019Xie 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.
PubMed 28159013Grieco 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.
PubMed 27875410
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy During Video-assisted Thoracoscopic Lobectomy
- ClinicalTrials.gov ID
- NCT03177564
- Acronym / sponsor ID
- XYFY-2017-033
- Conditions
- Pulmonary Complication, Thoracic Surgery
- Keywords
- driving pressure, one-lung ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 10 Jun 2018 (estimated)
- Study completion
- 10 Jun 2018 (estimated)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Protective Ventilation 1 | Active comparator | Procedure: Protective ventilation 1Intraoperatively 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%. |
| Protective Ventilation 2 | Active comparator | Procedure: Protective ventilation 2Intraoperatively 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. |
| Driving Pressure Limited Ventilation | Experimental | Procedure: Driving Pressure Limited VentilationThe intervention arm receives driving pressure limited ventilation during one-lung ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protective ventilation 1Low tidal volume, high inspired oygen fraction (FiO2) and recruitment maneuver. | Procedure or surgery | Protective Ventilation 1 |
| Protective ventilation 2Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver. | Procedure or surgery | Protective Ventilation 2 |
| Driving Pressure Limited VentilationPositive 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% | Procedure or surgery | Driving Pressure Limited Ventilation |
Primary outcome
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.
7 secondary outcomes
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
respiratory compliance
Time frame: during surgery
TNF-α
Time frame: the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation
IL-8
Time frame: the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation
ICU mortality
Time frame: Patients will be followed during the period of hospital stay, an expected average of 28 days
In-hospital mortality
Time frame: Patients will be followed during the period of hospital stay, an expected average of 28 days
28-day survival
Time frame: From day 0 to day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Results publication: PubMed 26947624Neto 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.
- Results publication: PubMed 24901240Mazo 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.
- Results publication: PubMed 20805178Agostini 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.
- Results publication: PubMed 26304285Hager 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.
- Results publication: PubMed 27894328Guerin 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.
- Results publication: PubMed 25693019Loring 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.
- Results publication: PubMed 28159013Xie 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.
- Results publication: PubMed 27875410Grieco 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.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Complication
Not yet recruiting
Low-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery
Postoperative Complications, Pulmonary Complication
RecruitingObservational study
Observational Study to Deeply Phenotype Major Organs in Sickle Cell Disease After Curative Therapies
Mortality in Sickle Cell, Sickle Cell Cardiopulmonary Complications
Not yet recruiting
AI-Assisted Education Before Surgery to Prevent Lung Complications in Older Surgical Patients
Postoperative Pulmonary Complications
Recruiting
PROtective Ventilation With FLOW-Controlled Ventilation
Postoperative Pulmonary Complications (PPCs), Feasibility Studies
Recruiting
Telerehabilitation Exercise Program for Postoperative Recovery in Lung Cancer.
Lung Neoplasms, Thoracic Surgery Lung
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protective ventilation 1, Protective ventilation 2 and Driving Pressure Limited Ventilation in people with Pulmonary Complication and Thoracic Surgery, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu gongjian, M.D/Ph.D (+86-13952203528, liugongjian61@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative pulmonary complications (time frame: within the first 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03177564, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017; AzTrials last refreshed its copy on 2 Nov 2026.