Surgical PatientsANTICIPUSCNCT03629431
Prophylactic Noninvasive Ventilation in vs Postoperative Standard Care in High Risk Patients According to ARISCAT Score
A study testing Prophylactic non-invasive ventilation in people with Surgical Patients and Pulmonary Complication, run by Institut Cancerologie de l'Ouest at 3 sites in France.
Trial summary
Postoperative pulmonary complications are one of the most common complications after surgery. Noninvasive ventilation has been proposed post-operatively to prevent postoperative pulmonary complications. Prophylactic noninvasive ventilation performed systematically in a non-specific population is without interest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Patients, Pulmonary Complication
- What is being tested?
- Prophylactic non-invasive ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Nov 2017to 16 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient 18 years of age or older
- Patient scheduled for surgery or considered semi-urgent (=pre-anesthesia consultation <48h before the surgical procedure) under General Anesthesia or under Loco-Regional Anesthesia
- Patient with an ARISCAT score higher than or equal to 45 - Obtaining the signed written consent of the patient
- Patient affiliated to a social security scheme
Who cannot join
- Minor patients, pregnant or lactating women
- Obstetrical interventions
- Surgery under Local Anesthesia or Peripheral Nerve,
- Interventions taking place outside an interventional room
- Interventions for previous surgical complications
- Second surgery during study
Show all 12Show fewer
- Organ transplantation
- Patients already intubated in preoperative
- Outpatient surgery
- Refusal of participation or inability to issue informed consent
- Person deprived of liberty or adult under guardianship
- Participation in another interventional study
Trial locations and contacts
3 sites in 1 country.
France3 sites
Chu D'Angers
Angers, 49000
Institut de Cancerologie de L'Ouest
Angers, 49000
Ch Du Mans
Le Mans, 72037
About this study
Official title: Multicenter, Randomized, Open Study, Assessing Prophylactic Noninvasive Ventilation in Intensive Care Unit vs Postoperative Standard Care for Patients With High Risk of Postoperative Pulmonary Complication With Preoperative ARISCAT Score
Postoperative pulmonary complications are one of the most common complications after surgery.
Noninvasive ventilation has been proposed post-operatively to prevent postoperative pulmonary complications.
Read more
Prophylactic noninvasive ventilation performed systematically in a non-specific population is without interest.
The difficulty for the practitioner is to target patients at higher risk of developing a postoperative pulmonary complications in order to guiding them to a post-operative specialized care pathway.
The use of the ARISCAT score, validated on a large European prospective cohort, makes it possible to evaluate, preoperatively, the risk of occurrence of postoperative pulmonary complication in the patient.
The hypothesis of the present research is that early postoperative preventive treatment with noninvasive ventilation, in patients at risk of postoperative pulmonary complications according to the preoperative evaluation according to the ARISCAT score, could have an interest in reducing these complications with a superior efficiency over standard techniques.
Read the detailed description
After verification of eligibility criteria and ARISCAT score, patients at high risk of COPD are randomized in the study.
At the exit of the operating room, patients are referred to the services according to their randomization arm :
- arm with prophylactic noninvasive ventilation in intensive care unit. Patients will receive noninvasive ventilation for a maximum of 48 hours. Sessions last 1 hour and are repeated every 2 to 3 hours
- arm with standard care in conventional care unit. Patients receive standard care such as physiotherapy.
In both arms, patient follow-up is 7 days maximum.
- Conditions
- Surgical Patients, Pulmonary Complication
- Being tested
- Prophylactic non-invasive ventilation, postoperative standard care
- Keywords
- ARISCAT, complications, postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic non-invasive ventilationProcedure or surgery
The sessions of NIV last 1 hour and are repeated every 2 to 3 hours with a goal of a daily assistance period of 6 to 8 hours for a minimum of 24 hours.
The sessions are spaced by periods of unassisted ventilation of 2 hours allowing the patient to rest, feed, receive care including physiotherapy sessions.
postoperative standard careProcedure or surgery
Standard care received postoperatively
| Study group | Role | What they receive |
|---|---|---|
| postoperative standard care | Active comparator | Standard care after surgery in postoperative unit Receives: Procedure: postoperative standard care |
| Prophylactic non-invasive ventilation | Experimental | Prophylactic noninvasive ventilation in postoperative and intensive care unit Receives: Procedure: Prophylactic non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First)
The outcome was reported as the count of participants who experienced acute respiratory failure, defined as the need for invasive or non-invasive mechanical ventilation within 7 days after surgery or until hospital discharge, whichever occurred first. All events were validated by an adjudication committee in this randomized, single-blind trial.
Measured: Up to 7 days post-surgery or until hospital discharge (study duration: 23 months)
Secondary outcomes (2)
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria)
The outcome was reported as the count of participants who developed healthcare-associated infections within 30 days after surgery, defined according to the Centers for Disease Control and Prevention (CDC) criteria. All events were validated by an adjudication committee
Measured: 30days
Reintubation Rate Within 7 Days
Number of patients reintubated
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start3 Nov 2017
- Primary completion16 Oct 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical PatientsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a study phase III, multicentre, comparative, randomized, controlled, superiority and open
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- DENIS DUPOIRON, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629431
- Sponsor's protocol ID
- ICO-A-2016-04
- Acronym
- ANTICIPUSC
- Status last verified
- Mar 2020
- First submitted
- 3 Jul 2018
- Last updated
- 27 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abrard S, Rineau E, Seegers V, Lebrec N, Sargentini C, Jeanneteau A, Longeau E, Caron S, Callahan JC, Chudeau N, Beloncle F, Lasocki S, Dupoiron D. Postoperative prophylactic intermittent noninvasive ventilation versus usual postoperative care for patients at high risk of pulmonary complications: a multicentre randomised trial. Br J Anaesth. 2023 Jan;130(1):e160-e168. doi: 10.1016/j.bja.2021.11.033. Epub 2022 Jan 5.
PubMed 34996593
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Open Study, Assessing Prophylactic Noninvasive Ventilation in Intensive Care Unit vs Postoperative Standard Care for Patients With High Risk of Postoperative Pulmonary Complication With Preoperative ARISCAT Score
- ClinicalTrials.gov ID
- NCT03629431
- Acronym / sponsor ID
- ANTICIPUSC / ICO-A-2016-04
- Conditions
- Surgical Patients, Pulmonary Complication
- Keywords
- ARISCAT, complications, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 16 Oct 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 27 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pulmonary complications are one of the most common complications after surgery.
Noninvasive ventilation has been proposed post-operatively to prevent postoperative pulmonary complications.
Prophylactic noninvasive ventilation performed systematically in a non-specific population is without interest.
The difficulty for the practitioner is to target patients at higher risk of developing a postoperative pulmonary complications in order to guiding them to a post-operative specialized care pathway.
The use of the ARISCAT score, validated on a large European prospective cohort, makes it possible to evaluate, preoperatively, the risk of occurrence of postoperative pulmonary complication in the patient.
The hypothesis of the present research is that early postoperative preventive treatment with noninvasive ventilation, in patients at risk of postoperative pulmonary complications according to the preoperative evaluation according to the ARISCAT score, could have an interest in reducing these complications with a superior efficiency over standard techniques.
Detailed description
After verification of eligibility criteria and ARISCAT score, patients at high risk of COPD are randomized in the study.
At the exit of the operating room, patients are referred to the services according to their randomization arm :
- arm with prophylactic noninvasive ventilation in intensive care unit. Patients will receive noninvasive ventilation for a maximum of 48 hours. Sessions last 1 hour and are repeated every 2 to 3 hours
- arm with standard care in conventional care unit. Patients receive standard care such as physiotherapy.
In both arms, patient follow-up is 7 days maximum.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a study phase III, multicentre, comparative, randomized, controlled, superiority and open
| Arm | Type | Receives |
|---|---|---|
| postoperative standard care | Active comparator | Procedure: postoperative standard careStandard care after surgery in postoperative unit |
| Prophylactic non-invasive ventilation | Experimental | Procedure: Prophylactic non-invasive ventilationProphylactic noninvasive ventilation in postoperative and intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient 18 years of age or older
- Patient scheduled for surgery or considered semi-urgent (=pre-anesthesia consultation <48h before the surgical procedure) under General Anesthesia or under Loco-Regional Anesthesia
- Patient with an ARISCAT score higher than or equal to 45 - Obtaining the signed written consent of the patient
- Patient affiliated to a social security scheme
Key exclusion criteria (12 listed)
- Minor patients, pregnant or lactating women
- Obstetrical interventions
- Surgery under Local Anesthesia or Peripheral Nerve,
- Interventions taking place outside an interventional room
- Interventions for previous surgical complications
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 |
|---|---|---|
| Prophylactic non-invasive ventilationThe sessions of NIV last 1 hour and are repeated every 2 to 3 hours with a goal of a daily assistance period of 6 to 8 hours for a minimum of 24 hours. The sessions are spaced by periods of unassisted ventilation of 2 hours allowing the patient to rest, feed, receive care including physiotherapy sessions. | Procedure or surgery | Prophylactic non-invasive ventilation |
| postoperative standard careStandard care received postoperatively | Procedure or surgery | postoperative standard care |
Primary outcome
Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First)
Time frame: Up to 7 days post-surgery or until hospital discharge (study duration: 23 months)
The outcome was reported as the count of participants who experienced acute respiratory failure, defined as the need for invasive or non-invasive mechanical ventilation within 7 days after surgery or until hospital discharge, whichever occurred first. All events were validated by an adjudication committee in this randomized, single-blind trial.
2 secondary outcomes
Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria)
Time frame: 30days
Reintubation Rate Within 7 Days
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34996593Abrard S, Rineau E, Seegers V, Lebrec N, Sargentini C, Jeanneteau A, Longeau E, Caron S, Callahan JC, Chudeau N, Beloncle F, Lasocki S, Dupoiron D. Postoperative prophylactic intermittent noninvasive ventilation versus usual postoperative care for patients at high risk of pulmonary complications: a multicentre randomised trial. Br J Anaesth. 2023 Jan;130(1):e160-e168. doi: 10.1016/j.bja.2021.11.033. Epub 2022 Jan 5.
- 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.
DENIS DUPOIRON, MD principal investigator
Institut de Cancérologie de l'Ouest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylactic non-invasive ventilation in people with Surgical Patients and Pulmonary Complication, run by Institut Cancerologie de l'Ouest at 3 sites 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 12 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 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First) (time frame: Up to 7 days post-surgery or until hospital discharge (study duration: 23 months)). 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 NCT03629431, 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 27 Jan 2026.