Respiration, ArtificialIMPREMONCT03976947
Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery
An observational study of Respiration, Artificial and Lung Diseases, run by University Hospital, Caen at 1 site in France.
Trial summary
In anesthesia the incidence of postoperative pulmonary complications is frequent, especially in cardiac surgery where the incidence can reach 10%. Respiratory morbidity in cardiac surgery is favored by multiple factors and is higher compared to anesthesia in "general" surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial, Lung Diseases, Atelectasis
- How many people
- 217 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2017to 28 Feb 2018
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients receiving cardiac surgery with cardiopulmonary bypass
Who may be able to join
- Patients receiving elective or urgent cardiac surgery with cardiopulmonary bypass
Who cannot join
- Emergency or salvage surgery
- Patient under guardianship
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery (IMPREMO): Before - After Trial
In anesthesia the incidence of postoperative pulmonary complications is frequent, especially in cardiac surgery where the incidence can reach 10%. Respiratory morbidity in cardiac surgery is favored by multiple factors and is higher compared to anesthesia in "general" surgery. The prevention of these complications is a major challenge in the management of patients.
Influence of driving pressure level on respiratory morbidity was first demonstrated in management of acute respiratory distress syndrome (ARDS) in resuscitation.
Read more
More recently, this notion has been introduced in anesthesia, with a correlation between increase driving pressure level and increase of post-operative respiratory complications.
A method should reduce these levels of driving pressure: performing lung recruitment maneuvers. This technique has been successfully tested in abdominal surgery in particular in a study published by Futier et al.. They systematized and standardized lung recruitment maneuvers and showed a decrease of postoperative pulmonary complications in abdominal surgery.
Thus, the realization of lung recruitment maneuvers, already used at the discretion of the practitioner, is now recommended by several teams of experts. The investigators propose in this "before-after" trial to evaluate variation in driving pressure due to systematic use of lung recruitment maneuvers, observed in patients operated in elective or urgent surgery. The secondary objective is to evaluate their impact on postoperative pulmonary complications.
Read the detailed description
This is a retrospective, before / after, monocentric trial.
- Conditions
- Respiration, Artificial, Lung Diseases, Atelectasis, Cardiac Surgical Procedures, Anesthesia, General
- Keywords
- Driving pressure, Postoperative pulmonary complications
- Medical subject headings
- Respiratory Aspiration, Lung Diseases, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Before group | The "before" group is the control group. We collect retrospective data in consecutive patients operated before the implementation of lung recruitment maneuvers protocol | |
| After group | We collect data in consecutive patients operated after the implementation of lung recruitment maneuvers protocol. This lung recruitment maneuvers will be realised along the surgery, (After tracheal intubation, per-CPB, post-CPB). Each recruitment maneuver consisted of applying a continuous positive airway pressure of 30 cm of water for 30 seconds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving pressure variation due to lung recruitment maneuvers
cmH2O
Measured: 1 day
Secondary outcomes (1)
Incidence of postoperative pulmonary complications
percentage
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 May 2017
- Primary completion30 Jan 2018
- Study completion28 Feb 2018
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 Respiration, ArtificialStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Brunet, MD, Principal investigator, University Hospital of Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976947
- Sponsor's protocol ID
- 17-023
- Acronym
- IMPREMO
- Status last verified
- Jun 2019
- First submitted
- 14 Apr 2017
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 26947624Futier 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 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lung Recruitment Maneuvers on Driving Pressure in Cardiac Surgery (IMPREMO): Before - After Trial
- ClinicalTrials.gov ID
- NCT03976947
- Acronym / sponsor ID
- IMPREMO / 17-023
- Conditions
- Respiration, Artificial, Lung Diseases, Atelectasis, Cardiac Surgical Procedures, Anesthesia, General
- Keywords
- Driving pressure, Postoperative pulmonary complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 6 Jun 2019 (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.
In anesthesia the incidence of postoperative pulmonary complications is frequent, especially in cardiac surgery where the incidence can reach 10%. Respiratory morbidity in cardiac surgery is favored by multiple factors and is higher compared to anesthesia in "general" surgery. The prevention of these complications is a major challenge in the management of patients.
Influence of driving pressure level on respiratory morbidity was first demonstrated in management of acute respiratory distress syndrome (ARDS) in resuscitation.
More recently, this notion has been introduced in anesthesia, with a correlation between increase driving pressure level and increase of post-operative respiratory complications.
A method should reduce these levels of driving pressure: performing lung recruitment maneuvers. This technique has been successfully tested in abdominal surgery in particular in a study published by Futier et al.. They systematized and standardized lung recruitment maneuvers and showed a decrease of postoperative pulmonary complications in abdominal surgery.
Thus, the realization of lung recruitment maneuvers, already used at the discretion of the practitioner, is now recommended by several teams of experts. The investigators propose in this "before-after" trial to evaluate variation in driving pressure due to systematic use of lung recruitment maneuvers, observed in patients operated in elective or urgent surgery. The secondary objective is to evaluate their impact on postoperative pulmonary complications.
Detailed description
This is a retrospective, before / after, monocentric trial.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before group | – | –The "before" group is the control group. We collect retrospective data in consecutive patients operated before the implementation of lung recruitment maneuvers protocol |
| After group | – | –We collect data in consecutive patients operated after the implementation of lung recruitment maneuvers protocol. This lung recruitment maneuvers will be realised along the surgery, (After tracheal intubation, per-CPB, post-CPB). Each recruitment maneuver consisted of applying a continuous positive airway pressure of 30 cm of water for 30 seconds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients receiving cardiac surgery with cardiopulmonary bypass
Key inclusion criteria (1 listed)
- Patients receiving elective or urgent cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (3 listed)
- Emergency or salvage surgery
- Patient under guardianship
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Driving pressure variation due to lung recruitment maneuvers
Time frame: 1 day
cmH2O
1 secondary outcome
Incidence of postoperative pulmonary complications
Time frame: baseline
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 21 Jan 2020.
- Background: 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.
- Background: 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.
- Individual participant dataSharing planned: No
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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.
Jennifer Brunet, MD principal investigator
University Hospital of Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiration, Artificial and Lung Diseases, run by University Hospital, Caen 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 1 inclusion and 3 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 21 Jan 2020. 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?
Driving pressure variation due to lung recruitment maneuvers (time frame: 1 day). 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 NCT03976947, 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 21 Jan 2020.