Acute Lung InjuryNCT01194895
A Trial to Evaluate the Impact of Lung-protective Intervention in Patients Undergoing Esophageal Cancer Surgery
A study testing protective ventilation and conventional ventilation in people with Acute Lung Injury, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of this trial is to determine whether low tidal volume during intraoperative one-lung ventilation could decrease the incidence rate of postoperative acute lung injury compared to "normal" tidal volume. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- protective ventilation and conventional ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Mar 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of esophageal carcinoma and planned for esophagectomy
- indication for one-lung ventilation
- informed consent
- ASA I~II
Who cannot join
- NYHA III~IV
- severe COPD
- pulmonary fibrosis
- any new pulmonary infiltrate on chest radiograph
- preoperative acute infection suspected
- altered liver function( Child-Pugh class B or moe)
- acute or chronic renal failure
- preoperative corticosteroid treatment during month before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Intraoperative Protective One-lung Ventilation in Patients Undergoing Esophagectomy : a Prospective Randomized Controlled Trial
The purpose of this trial is to determine whether low tidal volume during intraoperative one-lung ventilation could decrease the incidence rate of postoperative acute lung injury compared to "normal" tidal volume.
Read the detailed description
Large tidal volume are known risk factor of acute lung injury.Mechanical ventilation with low tidal volume has been shown to attenuate lung injuries in critically ill patients.Esophagectomy surgery need a relatively long time of one-lung ventilation. A normal tidal volume of two-lung ventilation should be a large one when exerted to one lung. We hypothesized that low tidal volume ventilation during one-lung ventilation could decrease incidence rate of postoperative acute lung injury and mortality.
- Conditions
- Acute Lung Injury
- Being tested
- protective ventilation, conventional ventilation
- Keywords
- esophagectomy, acute lung injury, protective ventilation
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protective ventilationOther
Also called low tidal volume ventilation
set tidal volume of 5ml/kg during one-lung ventilation
conventional ventilationOther
Also called normal tidal volume ventilation
keep tidal volume at 8ml/kg during one-lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| protective ventilation | Experimental | Not described Receives: Other: protective ventilation |
| conventional ventilation | Active comparator | Not described Receives: Other: conventional ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokines of bronchoalveolar lavage
TNF-a,IL-1b,IL-6,IL-8 of BAL will be measured with enzyme-linked immunoassay,all markers will be reported with a unit of pg/ml
Measured: 10 minutes before surgery ,at the end of surgery immediately
Secondary outcomes (6)
postoperative hospital days
duration of hospital stay after surgery
Measured: after surgery up to the time when patient is discharged or dead，it is an average
incidence rate of acute lung injury
Diagnosis of acute lung injury is followed the consensus criteria for ALI/ARDS published in "Am J Respir Crit Care Med 1994, 149:818-824".
Measured: after surgery up to 28 days
incidence rate of surgical complications
surgical complications include anastomotic fistula, postoperative infection and the patients will be followed until death or discharged
Measured: after surgery up to 28 days
inhospital mortality
the number of death in the period of hospital stay
Measured: after surgery up to 28 days
Oxygenation Index
Oxygenation Index=PaO2/FiO2
Measured: 10 minutes before surgery,at the end of surgery immediately,12h after surgery
CT scan of chest
Severity of pulmonary edema will be evaluated by CT scan of chest
Measured: 12 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Zhong, Shanghai Zhongshan Hospital
- Investigators
- Zhanggang Xue, professor, Study director, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194895
- Sponsor's protocol ID
- ESO-2010-LV
- Other IDs
- ESOPV
- Status last verified
- Mar 2013
- First submitted
- 18 Aug 2010
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Shen Y, Zhong M, Wu W, Wang H, Feng M, Tan L, Wang Q. The impact of tidal volume on pulmonary complications following minimally invasive esophagectomy: a randomized and controlled study. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1267-73; discussion 1273-4. doi: 10.1016/j.jtcvs.2013.06.043. Epub 2013 Aug 28.
PubMed 23993028
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Protective One-lung Ventilation in Patients Undergoing Esophagectomy : a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01194895
- Acronym / sponsor ID
- ESO-2010-LV
- Conditions
- Acute Lung Injury
- Keywords
- esophagectomy, acute lung injury, protective ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Sep 2010 (estimated)
- 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 purpose of this trial is to determine whether low tidal volume during intraoperative one-lung ventilation could decrease the incidence rate of postoperative acute lung injury compared to "normal" tidal volume.
Detailed description
Large tidal volume are known risk factor of acute lung injury.Mechanical ventilation with low tidal volume has been shown to attenuate lung injuries in critically ill patients.Esophagectomy surgery need a relatively long time of one-lung ventilation. A normal tidal volume of two-lung ventilation should be a large one when exerted to one lung. We hypothesized that low tidal volume ventilation during one-lung ventilation could decrease incidence rate of postoperative acute lung injury and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protective ventilation | Experimental | Other: protective ventilation |
| conventional ventilation | Active comparator | Other: conventional ventilation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of esophageal carcinoma and planned for esophagectomy
- indication for one-lung ventilation
- informed consent
- ASA I~II
Key exclusion criteria (8 listed)
- NYHA III~IV
- severe COPD
- pulmonary fibrosis
- any new pulmonary infiltrate on chest radiograph
- preoperative acute infection suspected
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 ventilationAlso: low tidal volume ventilationset tidal volume of 5ml/kg during one-lung ventilation | Other | protective ventilation |
| conventional ventilationAlso: normal tidal volume ventilationkeep tidal volume at 8ml/kg during one-lung ventilation | Other | conventional ventilation |
Primary outcome
cytokines of bronchoalveolar lavage
Time frame: 10 minutes before surgery ,at the end of surgery immediately
TNF-a,IL-1b,IL-6,IL-8 of BAL will be measured with enzyme-linked immunoassay,all markers will be reported with a unit of pg/ml
6 secondary outcomes
postoperative hospital days
Time frame: after surgery up to the time when patient is discharged or dead，it is an average
incidence rate of acute lung injury
Time frame: after surgery up to 28 days
incidence rate of surgical complications
Time frame: after surgery up to 28 days
inhospital mortality
Time frame: after surgery up to 28 days
Oxygenation Index
Time frame: 10 minutes before surgery,at the end of surgery immediately,12h after surgery
CT scan of chest
Time frame: 12 hours after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
- Derived from this study: PubMed 23993028Shen Y, Zhong M, Wu W, Wang H, Feng M, Tan L, Wang Q. The impact of tidal volume on pulmonary complications following minimally invasive esophagectomy: a randomized and controlled study. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1267-73; discussion 1273-4. doi: 10.1016/j.jtcvs.2013.06.043. Epub 2013 Aug 28.
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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.
Zhanggang Xue, professor study director
Shanghai Zhongshan Hospital
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 and conventional ventilation in people with Acute Lung Injury, run by Shanghai Zhongshan Hospital 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 4 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: finished, as of the sponsor's last update on 14 Mar 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokines of bronchoalveolar lavage (time frame: 10 minutes before surgery ,at the end of surgery immediately). 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 NCT01194895, which also lists 1 linked publication.
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 14 Mar 2013.