Pulmonary Complication Clinical Trial
— ANTICIPUSCOfficial 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.
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.
Status | Recruiting |
Enrollment | 266 |
Est. completion date | June 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu D'Angers | Angers | |
France | Institut de Cancerologie de L'Ouest | Angers | |
France | Ch Du Mans | Le Mans |
Lead Sponsor | Collaborator |
---|---|
Institut Cancerologie de l'Ouest | Direction Générale de l'Offre de Soins |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the efficiency of a standard care to a preventative postoperative care strategy by noninvasive ventilation | The occurrence of an acute respiratory failure within the 7 days after surgery in intra-hospital validated by the adjudication comity, randomized, single-blind trial. | 19 months | |
Secondary | Security and innocuousness of the study strategy | All adverse events due to study strategy | 19 months | |
Secondary | Mortality during hospitalization for surgery | Death whatever the cause during hospitalization for surgery (maximum 7 days) | 19 months | |
Secondary | An effect on the reintubation of patients | Reason and elay of reintubation | 19 months | |
Secondary | An effect on duration of stay in ongoing monitoring unit/reanimation and on invasive or not mechanical ventilation | The number of days of invasive mechanical ventilation, or non-invasive mechanical ventilation, | 19 months |
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