Lung NeoplasmsVPPNCT00805077
Pulmonary Surgery and Protective Mechanical Ventilation
A study testing mechanical ventilation and tidal volume in people with Lung Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this trial is to evaluate the efficacy and the safety of lung protective ventilation during anesthesia in patients undergoing pneumonectomy or lobectomy for lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- mechanical ventilation and tidal volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Jul 2012
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary lung cancer.
- Elective Pneumonectomy or lobectomy or bilobectomy
- Written informed consent
Who cannot join
- Patients undergoing surgical procedure other than pneumonectomy or lobectomy or bilobectomy
- Mesothelioma
- Liver cirrhosis
- Chronic renal failure
- Need for mechanical ventilation or non invasive ventilation (CPAP for obstructive sleep apnea syndrome for example) before surgery
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to evaluate the efficacy and the safety of lung protective ventilation during anesthesia in patients undergoing pneumonectomy or lobectomy for lung cancer.
Read the detailed description
Extended description of the protocol could be provided by the URC-EST, SAINT ANTOINE HOSPITAL, University of Paris-VI and by principal investigator.
Pneumonectomy or lobectomy is associated with a high risk for postoperative complication. The benefit of lung protective ventilation with low tidal volume has been demonstrated in patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). Recent clinical studies have suggested that mechanical ventilation with low tidal volume may also profit in others setting. Lung protective ventilation during anaesthesia has been found to limit the inflammatory response in the lung and to decrease postoperative systemic inflammatory response. However, others trials did not found benefit of protective ventilation strategy during anaesthesia.
This study will be a randomized, controlled, doubled blind trial comparing two management ventilator strategies during anaesthesia for thoracotomy. Only patients undergoing pneumonectomy or lobectomy for lung primitive cancer will be included in this trial. During anesthesia, one group will receive mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP and the other will receive tidal volume of 10 ml/kg of ideal body weight without PEEP. After surgery, data concerning oxygen delivery, blood analysis, complications, cancer recurrence and death will be collected.
- Conditions
- Lung Neoplasms
- Being tested
- mechanical ventilation, tidal volume
- Keywords
- interoperative care, Tidal volume, Postoperative complications, Pneumonectomy, Lobectomy, Mechanical ventilation
- Medical subject headings
- Lung Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationProcedure or surgery
mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
tidal volumeOther
tidal volume of 10 ml/kg of ideal body weight without PEEP
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP Receives: Procedure: mechanical ventilation |
| 2 | Other | tidal volume of 10 ml/kg of ideal body weight without PEEP Receives: Other: tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major postoperative complications during the first 30 days after surgery
Measured: the first 30 days after surgery
Secondary outcomes (1)
Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, death
Measured: during the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2011
- Study completionJul 2012
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 Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Marret, MD, Principal investigator, Hopital Tenon, Assistance Publique - Hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805077
- Sponsor's protocol ID
- P070119
- Acronym
- VPP
- Status last verified
- Jul 2013
- First submitted
- 8 Dec 2008
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Marret E, Cinotti R, Berard L, Piriou V, Jobard J, Barrucand B, Radu D, Jaber S, Bonnet F; and the PPV study group. Protective ventilation during anaesthesia reduces major postoperative complications after lung cancer surgery: A double-blind randomised controlled trial. Eur J Anaesthesiol. 2018 Oct;35(10):727-735. doi: 10.1097/EJA.0000000000000804.
PubMed 29561278
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Surgery and Protective Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00805077
- Acronym / sponsor ID
- VPP / P070119
- Conditions
- Lung Neoplasms
- Keywords
- interoperative care, Tidal volume, Postoperative complications, Pneumonectomy, Lobectomy, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Dec 2008 (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 evaluate the efficacy and the safety of lung protective ventilation during anesthesia in patients undergoing pneumonectomy or lobectomy for lung cancer.
Detailed description
Extended description of the protocol could be provided by the URC-EST, SAINT ANTOINE HOSPITAL, University of Paris-VI and by principal investigator.
Pneumonectomy or lobectomy is associated with a high risk for postoperative complication. The benefit of lung protective ventilation with low tidal volume has been demonstrated in patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). Recent clinical studies have suggested that mechanical ventilation with low tidal volume may also profit in others setting. Lung protective ventilation during anaesthesia has been found to limit the inflammatory response in the lung and to decrease postoperative systemic inflammatory response. However, others trials did not found benefit of protective ventilation strategy during anaesthesia.
This study will be a randomized, controlled, doubled blind trial comparing two management ventilator strategies during anaesthesia for thoracotomy. Only patients undergoing pneumonectomy or lobectomy for lung primitive cancer will be included in this trial. During anesthesia, one group will receive mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP and the other will receive tidal volume of 10 ml/kg of ideal body weight without PEEP. After surgery, data concerning oxygen delivery, blood analysis, complications, cancer recurrence and death will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: mechanical ventilationmechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP |
| 2 | Other | Other: tidal volumetidal volume of 10 ml/kg of ideal body weight without PEEP |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary lung cancer.
- Elective Pneumonectomy or lobectomy or bilobectomy
- Written informed consent
Key exclusion criteria (6 listed)
- Patients undergoing surgical procedure other than pneumonectomy or lobectomy or bilobectomy
- Mesothelioma
- Liver cirrhosis
- Chronic renal failure
- Need for mechanical ventilation or non invasive ventilation (CPAP for obstructive sleep apnea syndrome for example) before surgery
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 |
|---|---|---|
| mechanical ventilationmechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP | Procedure or surgery | 1 |
| tidal volumetidal volume of 10 ml/kg of ideal body weight without PEEP | Other | 2 |
Primary outcome
Major postoperative complications during the first 30 days after surgery
Time frame: the first 30 days after surgery
1 secondary outcome
Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, death
Time frame: during the first 30 days after 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 29 Jul 2013.
- Derived from this study: PubMed 29561278Marret E, Cinotti R, Berard L, Piriou V, Jobard J, Barrucand B, Radu D, Jaber S, Bonnet F; and the PPV study group. Protective ventilation during anaesthesia reduces major postoperative complications after lung cancer surgery: A double-blind randomised controlled trial. Eur J Anaesthesiol. 2018 Oct;35(10):727-735. doi: 10.1097/EJA.0000000000000804.
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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.
Emmanuel Marret, MD principal investigator
Hopital Tenon, Assistance Publique - Hopitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical ventilation and tidal volume in people with Lung Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 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 29 Jul 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 France. 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?
Major postoperative complications during the first 30 days after surgery (time frame: the first 30 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 NCT00805077, 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 29 Jul 2013.