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| Name | Class |
|---|---|
| Direction Générale de l'Offre de Soins | OTHER_GOV |
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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.
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 :
In both arms, patient follow-up is 7 days maximum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| postoperative standard care | Active Comparator | Standard care after surgery in postoperative unit |
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| Prophylactic non-invasive ventilation | Experimental | Prophylactic noninvasive ventilation in postoperative and intensive care unit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylactic non-invasive ventilation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 7 days post-surgery or until hospital discharge (study duration: 23 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DENIS DUPOIRON, MD | Institut de Cancérologie de l'Ouest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu D'Angers | Angers | 49000 | France | |||
| Institut de Cancerologie de L'Ouest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34996593 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Postoperative Standard Care | Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively |
| FG001 | Prophylactic Non-invasive Ventilation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2019 |
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This is a study phase III, multicentre, comparative, randomized, controlled, superiority and open
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| postoperative standard care | Procedure | Standard care received postoperatively |
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| Reintubation Rate Within 7 Days | Number of patients reintubated | 7 days |
| Angers |
| 49000 |
| France |
| Ch Du Mans | Le Mans | 72037 | France |
Prophylactic noninvasive ventilation in postoperative and intensive care unit
Prophylactic non-invasive ventilation: 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.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Postoperative Standard Care | Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively |
| BG001 | Prophylactic Non-invasive Ventilation | Prophylactic noninvasive ventilation in postoperative and intensive care unit Prophylactic non-invasive ventilation: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 7 days post-surgery or until hospital discharge (study duration: 23 months) |
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| Secondary | 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 | Posted | Count of Participants | Participants | 30days |
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| Secondary | Reintubation Rate Within 7 Days | Number of patients reintubated | Posted | Count of Participants | Participants | 7 days |
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From signature of consent to the end of follow up (30 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Postoperative Standard Care | Standard care after surgery in postoperative unit postoperative standard care: Standard care received postoperatively | 2 | 128 | 19 | 128 | 128 | 128 |
| EG001 | Prophylactic Non-invasive Ventilation | Prophylactic noninvasive ventilation in postoperative and intensive care unit Prophylactic non-invasive ventilation: 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. | 3 | 125 | 15 | 125 | 125 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
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| Stroke | Nervous system disorders | Non-systematic Assessment |
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| cardiogenic shock | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| cholecystisis | Hepatobiliary disorders | Non-systematic Assessment |
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| Convulsive seizure | Psychiatric disorders | Non-systematic Assessment |
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| Hemodynamic failure | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Cardiac rythm disorders | Cardiac disorders | Non-systematic Assessment |
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| bronchail congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Pericardial effusion | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
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| Inhalation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
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| food intolerance | General disorders | Non-systematic Assessment |
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| mediastinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| pneumopathy | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Multiple organ failure | General disorders | Non-systematic Assessment |
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| Bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chirurgical complication | General disorders | Non-systematic Assessment |
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| Cardiovascular disorders | Cardiac disorders | Non-systematic Assessment |
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| Multiple organ failure | General disorders | Non-systematic Assessment |
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| Digestive disorders | Gastrointestinal disorders | Non-systematic Assessment |
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| psycahtric disorders | Psychiatric disorders | Non-systematic Assessment |
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| Infection | Infections and infestations | Non-systematic Assessment |
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| Complications of non-invasive ventilation | General disorders | Non-systematic Assessment |
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| Postoperative Pulmonary Complication | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Denis DUPOIRON | INSTITUT DE CANCEROLOGIE DE L'OUEST | 241352700 | +33 | denis.dupoiron@ico.unicancer.fr |
| Jan 7, 2026 |
| Prot_SAP_000.pdf |
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