Pulmonary ComplicationNCT03174743
Protective Ventilation During Pulmonary Lobectomy
A study testing Convential Ventilation 1, Convential Ventilation 2 and Protective Ventilation 1 in people with Pulmonary Complication and Thoracic Surgery, run by Xuzhou Medical University at 1 site in China.
Trial summary
The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pulmonary Complication, Thoracic Surgery, Inflammation
- What is being tested?
- Convential Ventilation 1, Convential Ventilation 2 and Protective Ventilation 1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2017to 1 Jul 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.20 Years and older 2.Patients undergoing pulmonary lobectomy
Who cannot join
- Emergency surgery
- Pulmonary hypertension
- Forced vital capacity or forced expiratory volume in 1 sec < 50% 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Liu Su Liu, MD/Ph.D, +86-18118309692, xyfymzk@163.com
About this study
Official title: The Effect of Protective Ventilation During Pulmonary Lobectomy
The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.
Read the detailed description
The hypothesis is that application of low tidal volume, moderate inspired oxygen fraction (FiO2) ,intermittent alveolar recruitment and positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in patients.
- Conditions
- Pulmonary Complication, Thoracic Surgery, Inflammation
- Being tested
- Convential Ventilation 1, Convential Ventilation 2, Protective Ventilation 1, Protective Ventilation 2
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convential Ventilation 1Procedure or surgery
High tidal volume, moderate inspired oygen fraction (FiO2).
Convential Ventilation 2Procedure or surgery
High tidal volume, high inspired oygen fraction (FiO2).
Protective Ventilation 1Procedure or surgery
Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
Protective Ventilation 2Procedure or surgery
Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver.
| Study group | Role | What they receive |
|---|---|---|
| Convential Ventilation 1 | Placebo 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 of 60%. Receives: Procedure: Convential Ventilation 1 |
| Convential Ventilation 2 | Placebo 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: Convential Ventilation 2 |
| Protective ventilation 1 | Active comparator | Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 60% with lung recruitment maneuvers. 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 6 cmH2O and a FiO2 of 100% with lung recruitment maneuvers. Receives: Procedure: Protective Ventilation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with pulmonary complication
The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism.
Measured: up to postoperative 3days
Secondary outcomes (4)
PaO2 /FiO2
Measured: 10 min after induction, 30 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: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
IL6
Measured: 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
IL10
Measured: 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start2 Jun 2017
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jul 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Liu, Xuzhou Medical University
- Investigators
- Liu Su Liu, M.D/Ph.D, Principal investigator, 徐州医科大学附属医院医学
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174743
- Sponsor's protocol ID
- XYFY-2017-033
- Status last verified
- Jun 2017
- First submitted
- 30 May 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: IPD will be available when this trial is finished and the article have been published.
Publications
Theroux MC, Fisher AO, Horner LM, Rodriguez ME, Costarino AT, Miller TL, Shaffer TH. Protective ventilation to reduce inflammatory injury from one lung ventilation in a piglet model. Paediatr Anaesth. 2010 Apr;20(4):356-64. doi: 10.1111/j.1460-9592.2009.03195.x. Epub 2009 Nov 16.
PubMed 19919624Fuller BM, Mohr NM, Drewry AM, Carpenter CR. Lower tidal volume at initiation of mechanical ventilation may reduce progression to acute respiratory distress syndrome: a systematic review. Crit Care. 2013 Jan 18;17(1):R11. doi: 10.1186/cc11936.
PubMed 23331507Kozian A, Schilling T, Schutze H, Senturk M, Hachenberg T, Hedenstierna G. Ventilatory protective strategies during thoracic surgery: effects of alveolar recruitment maneuver and low-tidal volume ventilation on lung density distribution. Anesthesiology. 2011 May;114(5):1025-35. doi: 10.1097/ALN.0b013e3182164356.
PubMed 21436678Licker M, Diaper J, Villiger Y, Spiliopoulos A, Licker V, Robert J, Tschopp JM. Impact of intraoperative lung-protective interventions in patients undergoing lung cancer surgery. Crit Care. 2009;13(2):R41. doi: 10.1186/cc7762. Epub 2009 Mar 24.
PubMed 19317902Ishikawa S. Alveolar recruitment maneuver as an important part of protective one-lung ventilation. J Anesth. 2012 Oct;26(5):794-5. doi: 10.1007/s00540-012-1396-4. Epub 2012 May 3. No abstract available.
PubMed 22552387Yang M, Ahn HJ, Kim K, Kim JA, Yi CA, Kim MJ, Kim HJ. Does a protective ventilation strategy reduce the risk of pulmonary complications after lung cancer surgery?: a randomized controlled trial. Chest. 2011 Mar;139(3):530-537. doi: 10.1378/chest.09-2293. Epub 2010 Sep 9.
PubMed 20829341Kim SH, Jung KT, An TH. Effects of tidal volume and PEEP on arterial blood gases and pulmonary mechanics during one-lung ventilation. J Anesth. 2012 Aug;26(4):568-73. doi: 10.1007/s00540-012-1348-z. Epub 2012 Feb 18.
PubMed 22349751Ahn HJ, Kim JA, Yang M, Shim WS, Park KJ, Lee JJ. Comparison between conventional and protective one-lung ventilation for ventilator-assisted thoracic surgery. Anaesth Intensive Care. 2012 Sep;40(5):780-8. doi: 10.1177/0310057X1204000505.
PubMed 22934859
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
- The Effect of Protective Ventilation During Pulmonary Lobectomy
- ClinicalTrials.gov ID
- NCT03174743
- Acronym / sponsor ID
- XYFY-2017-033
- Conditions
- Pulmonary Complication, Thoracic Surgery, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jul 2018 (estimated)
- First posted
- 2 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.
The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.
Detailed description
The hypothesis is that application of low tidal volume, moderate inspired oxygen fraction (FiO2) ,intermittent alveolar recruitment and positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Convential Ventilation 1 | Placebo comparator | Procedure: Convential 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 of 60%. |
| Convential Ventilation 2 | Placebo comparator | Procedure: Convential Ventilation 2Intraoperatively 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 1 | Active comparator | Procedure: Protective Ventilation 1Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 60% with lung recruitment maneuvers. |
| 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 6 cmH2O and a FiO2 of 100% with lung recruitment maneuvers. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.20 Years and older 2.Patients undergoing pulmonary lobectomy
Key exclusion criteria (8 listed)
- Emergency surgery
- Pulmonary hypertension
- Forced vital capacity or forced expiratory volume in 1 sec < 50% of the predicted values
- Coagulation disorder
- Pulmonary or extrapulmonary infections
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 |
|---|---|---|
| Convential Ventilation 1High tidal volume, moderate inspired oygen fraction (FiO2). | Procedure or surgery | Convential Ventilation 1 |
| Convential Ventilation 2High tidal volume, high inspired oygen fraction (FiO2). | Procedure or surgery | Convential Ventilation 2 |
| Protective Ventilation 1Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver. | Procedure or surgery | Protective ventilation 1 |
| Protective Ventilation 2Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver. | Procedure or surgery | Protective ventilation 2 |
Primary outcome
The proportion of patients with pulmonary complication
Time frame: up to postoperative 3days
The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism.
4 secondary outcomes
PaO2 /FiO2
Time frame: 10 min after induction, 30 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: 10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
IL6
Time frame: 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
IL10
Time frame: 10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation
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 19919624Theroux MC, Fisher AO, Horner LM, Rodriguez ME, Costarino AT, Miller TL, Shaffer TH. Protective ventilation to reduce inflammatory injury from one lung ventilation in a piglet model. Paediatr Anaesth. 2010 Apr;20(4):356-64. doi: 10.1111/j.1460-9592.2009.03195.x. Epub 2009 Nov 16.
- Results publication: PubMed 23331507Fuller BM, Mohr NM, Drewry AM, Carpenter CR. Lower tidal volume at initiation of mechanical ventilation may reduce progression to acute respiratory distress syndrome: a systematic review. Crit Care. 2013 Jan 18;17(1):R11. doi: 10.1186/cc11936.
- Results publication: PubMed 21436678Kozian A, Schilling T, Schutze H, Senturk M, Hachenberg T, Hedenstierna G. Ventilatory protective strategies during thoracic surgery: effects of alveolar recruitment maneuver and low-tidal volume ventilation on lung density distribution. Anesthesiology. 2011 May;114(5):1025-35. doi: 10.1097/ALN.0b013e3182164356.
- Results publication: PubMed 19317902Licker M, Diaper J, Villiger Y, Spiliopoulos A, Licker V, Robert J, Tschopp JM. Impact of intraoperative lung-protective interventions in patients undergoing lung cancer surgery. Crit Care. 2009;13(2):R41. doi: 10.1186/cc7762. Epub 2009 Mar 24.
- Results publication: PubMed 22552387Ishikawa S. Alveolar recruitment maneuver as an important part of protective one-lung ventilation. J Anesth. 2012 Oct;26(5):794-5. doi: 10.1007/s00540-012-1396-4. Epub 2012 May 3. No abstract available.
- Results publication: PubMed 20829341Yang M, Ahn HJ, Kim K, Kim JA, Yi CA, Kim MJ, Kim HJ. Does a protective ventilation strategy reduce the risk of pulmonary complications after lung cancer surgery?: a randomized controlled trial. Chest. 2011 Mar;139(3):530-537. doi: 10.1378/chest.09-2293. Epub 2010 Sep 9.
- Results publication: PubMed 22349751Kim SH, Jung KT, An TH. Effects of tidal volume and PEEP on arterial blood gases and pulmonary mechanics during one-lung ventilation. J Anesth. 2012 Aug;26(4):568-73. doi: 10.1007/s00540-012-1348-z. Epub 2012 Feb 18.
- Results publication: PubMed 22934859Ahn HJ, Kim JA, Yang M, Shim WS, Park KJ, Lee JJ. Comparison between conventional and protective one-lung ventilation for ventilator-assisted thoracic surgery. Anaesth Intensive Care. 2012 Sep;40(5):780-8. doi: 10.1177/0310057X1204000505.
- Individual participant dataSharing planned: No. IPD will be available when this trial is finished and the article have been published.
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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.
Liu Su Liu, M.D/Ph.D principal investigator
徐州医科大学附属医院医学
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Convential Ventilation 1, Convential Ventilation 2 and Protective Ventilation 1 in people with Pulmonary Complication and Thoracic Surgery, run by 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 1 inclusion and 8 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. Some participants in this study may receive a placebo. 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 Su Liu, M.D/Ph.D (86-18118309692, xyfymzk@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with pulmonary complication (time frame: up to postoperative 3days). 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 NCT03174743, 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.