Protective Lung Ventilation Using:Phase 4NCT01282996
Intraoperative Protective Ventilation in Abdominal Surgery (IMPROVE Study)
A Phase 4 study testing Abdominal surgery in people with Protective Lung Ventilation Using: and Low Tidal Volume (6-8 mL/kg Predicted Body Weight), run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The purpose of this study is to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Protective Lung Ventilation Using:, Low Tidal Volume (6-8 mL/kg Predicted Body Weight), PEEP of 6-8 cmH2O
- What is being tested?
- Abdominal surgery
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Aug 2012
- Phase
- Phase 4
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned intrabdominal surgery
- Expected duration ≥ 2 hours
- Age ≥ 40 yr (and <90 yr)
- Risk of postoperative pulmonary complications (Arozullah score ≥2)
Who cannot join
- Noninvasive ventilation in the last 30 days
- Recent history of pneumonia, ALI/ARDS (in the last 30 days)
- History of pulmonary resection
- History of neuromuscular disease
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study
The purpose of this study is to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery.
Read the detailed description
Postoperative complications are associated with a significant and quantifiable rate of both morbidity and mortality, increased length of hospital stay and cost of care. Intra-abdominal surgery, especially upper abdominal surgery, is an important risk factor of both pulmonary and extra-pulmonary complications. Up to 15-20% of patients will develop postoperative respiratory failure which may require respiratory support.
Recent data from both experimental and clinical studies suggested that, compared with conventional ventilation using high tidal volume (TV) without positive end-expiratory pressure (PEEP), intraoperative lung protective ventilation using low tidal volume, PEEP and recruitment maneuvers (RM) could reduce postoperative complications. Conventional ventilation promotes sustained cytokine production and could therefore contribute to development of lung injury with in patients with normal lungs. Conversely, lung protective ventilation was found to reduce pulmonary and systemic inflammation.
The primary objective is to compare a lung protective ventilation with conventional ventilation (high tidal volumes without PEEP) during abdominal surgery: 1- Conventional ventilation with TV of 10-12 mL/kg predicted body weight (PBW) without PEEP; 2- Protective lung ventilation with TV of 6-8 mL/kg PBW, PEEP of 6-8 cmH2O and RM.
Our hypothesis is that lung protective ventilation could reduce postoperative pulmonary and extra-pulmonary complications compared with conventional ventilation.
- Conditions
- Protective Lung Ventilation Using:, Low Tidal Volume (6-8 mL/kg Predicted Body Weight), PEEP of 6-8 cmH2O, Intraoperative RMs
- Being tested
- Abdominal surgery
- Keywords
- Mechanical ventilation, Postoperative pulmonary complications, Positive end-expiratory pressure, Protective lung ventilation, Alveolar recruitment maneuver, General anesthesia, Abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal surgeryOther
to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint defined as incidence of major postoperative pulmonary (defined as pneumonia, need for noninvasive ventilation or need for invasive ventilation) and extrapulmonary (SIRS, sepsis and septic shock) complications
Measured: during the first seven days after surgery
Secondary outcomes (10)
Major complications: postoperative hypoxemia, postoperative pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pulmonary embolism
Measured: at day 15 after surgery
Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess
Measured: at day 15 after surgery
Other postoperative complications (reintervention, wound abscess, ...)
Measured: at day 15 after surgery
Systemic level of marker of inflammation (C Reactive protein)
Measured: at day 15 after surgery
Postoperative complications at day 30 after surgery
Measured: at day 30 after surgery
Need for ICU admission
Measured: at day 30 after surgery
ICU length of stay
Measured: at day 30 after surgery
Hospital length of stay
Measured: at day 30 after surgery
Mortality
Measured: at day 30 after surgery
Plasma levels of the soluble form of the receptor for advanced glycation end-products (sRAGE), a marker of alveolar type I cell injury
Measured: before surgery, during the immediate postoperative period and on day 1, day 3 and day 7 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Protective Lung Ventilation Using:Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282996
- Sponsor's protocol ID
- CHU-0087
- Status last verified
- Oct 2012
- First submitted
- 18 Jan 2011
- Last updated
- 5 Oct 2012
- Results posted
- No
Publications
Neuschwander A, Futier E, Jaber S, Pereira B, Eurin M, Marret E, Szymkewicz O, Beaussier M, Paugam-Burtz C. The effects of intraoperative lung protective ventilation with positive end-expiratory pressure on blood loss during hepatic resection surgery: A secondary analysis of data from a published randomised control trial (IMPROVE). Eur J Anaesthesiol. 2016 Apr;33(4):292-8. doi: 10.1097/EJA.0000000000000390.
PubMed 26716865Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
PubMed 23902482
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Lung Protective Ventilation in Abdominal Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01282996
- Acronym / sponsor ID
- CHU-0087
- Conditions
- Protective Lung Ventilation Using:, Low Tidal Volume (6-8 mL/kg Predicted Body Weight), PEEP of 6-8 cmH2O, Intraoperative RMs
- Keywords
- Mechanical ventilation, Postoperative pulmonary complications, Positive end-expiratory pressure, Protective lung ventilation, Alveolar recruitment maneuver, General anesthesia, Abdominal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Jan 2011 (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 study is to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery.
Detailed description
Postoperative complications are associated with a significant and quantifiable rate of both morbidity and mortality, increased length of hospital stay and cost of care. Intra-abdominal surgery, especially upper abdominal surgery, is an important risk factor of both pulmonary and extra-pulmonary complications. Up to 15-20% of patients will develop postoperative respiratory failure which may require respiratory support.
Recent data from both experimental and clinical studies suggested that, compared with conventional ventilation using high tidal volume (TV) without positive end-expiratory pressure (PEEP), intraoperative lung protective ventilation using low tidal volume, PEEP and recruitment maneuvers (RM) could reduce postoperative complications. Conventional ventilation promotes sustained cytokine production and could therefore contribute to development of lung injury with in patients with normal lungs. Conversely, lung protective ventilation was found to reduce pulmonary and systemic inflammation.
The primary objective is to compare a lung protective ventilation with conventional ventilation (high tidal volumes without PEEP) during abdominal surgery: 1- Conventional ventilation with TV of 10-12 mL/kg predicted body weight (PBW) without PEEP; 2- Protective lung ventilation with TV of 6-8 mL/kg PBW, PEEP of 6-8 cmH2O and RM.
Our hypothesis is that lung protective ventilation could reduce postoperative pulmonary and extra-pulmonary complications compared with conventional ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned intrabdominal surgery
- Expected duration ≥ 2 hours
- Age ≥ 40 yr (and <90 yr)
- Risk of postoperative pulmonary complications (Arozullah score ≥2)
Key exclusion criteria (5 listed)
- Noninvasive ventilation in the last 30 days
- Recent history of pneumonia, ALI/ARDS (in the last 30 days)
- History of pulmonary resection
- History of neuromuscular disease
- Patient refusal
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 |
|---|---|---|
| Abdominal surgeryto compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery | Other | – |
Primary outcome
Composite endpoint defined as incidence of major postoperative pulmonary (defined as pneumonia, need for noninvasive ventilation or need for invasive ventilation) and extrapulmonary (SIRS, sepsis and septic shock) complications
Time frame: during the first seven days after surgery
10 secondary outcomes
Major complications: postoperative hypoxemia, postoperative pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pulmonary embolism
Time frame: at day 15 after surgery
Minor complications : atelectasis, anastomotic leakage, intrabdominal abscess
Time frame: at day 15 after surgery
Other postoperative complications (reintervention, wound abscess, ...)
Time frame: at day 15 after surgery
Systemic level of marker of inflammation (C Reactive protein)
Time frame: at day 15 after surgery
Postoperative complications at day 30 after surgery
Time frame: at day 30 after surgery
Need for ICU admission
Time frame: at day 30 after surgery
ICU length of stay
Time frame: at day 30 after surgery
Hospital length of stay
Time frame: at day 30 after surgery
Mortality
Time frame: at day 30 after surgery
Plasma levels of the soluble form of the receptor for advanced glycation end-products (sRAGE), a marker of alveolar type I cell injury
Time frame: before surgery, during the immediate postoperative period and on day 1, day 3 and day 7 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 5 Oct 2012.
- Derived from this study: PubMed 26716865Neuschwander A, Futier E, Jaber S, Pereira B, Eurin M, Marret E, Szymkewicz O, Beaussier M, Paugam-Burtz C. The effects of intraoperative lung protective ventilation with positive end-expiratory pressure on blood loss during hepatic resection surgery: A secondary analysis of data from a published randomised control trial (IMPROVE). Eur J Anaesthesiol. 2016 Apr;33(4):292-8. doi: 10.1097/EJA.0000000000000390.
- Derived from this study: PubMed 23902482Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abdominal surgery in people with Protective Lung Ventilation Using: and Low Tidal Volume (6-8 mL/kg Predicted Body Weight), run by University Hospital, Clermont-Ferrand 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 4 inclusion and 5 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 5 Oct 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite endpoint defined as incidence of major postoperative pulmonary (defined as pneumonia, need for noninvasive ventilation or need for invasive ventilation) and extrapulmonary (SIRS, sepsis and septic shock) complications (time frame: during the first seven 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 NCT01282996, which also lists 2 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 5 Oct 2012.