Pulmonary Complication, Surgical Patients
Conditions
Keywords
ARISCAT, complications, postoperative
Brief 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. 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.
Interventions
PROCEDUREProphylactic 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.
PROCEDUREpostoperative standard care
Standard care received postoperatively
Sponsors
Institut Cancerologie de l'Ouest
Direction Générale de l'Offre de Soins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a study phase III, multicentre, comparative, randomized, controlled, superiority and open
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Acute Respiratory Failure Within the First 7 Days Following Surgery (or Until Hospital Discharge if Occurring First) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Healthcare-Associated Infections Within 30 Days After Surgery (Defined According to CDC Criteria) | 30days | 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 |
| Reintubation Rate Within 7 Days | 7 days | Number of patients reintubated |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDENIS DUPOIRON, MD
Institut de Cancérologie de l'Ouest
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 10.5 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 203 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 128 | 3 / 125 |
| other Total, other adverse events | 128 / 128 | 125 / 125 |
| serious Total, serious adverse events | 19 / 128 | 15 / 125 |
Outcome results
None listed