Mechanical Power for Ventilatory Settings in Operating Room (IMPROVEIII)
Mechanical Power for Ventilatory Settings in Operating Room: a Multicenter Randomized Controlled Trial
Postoperative respiratory failure (PRF) is a dreaded complication that imposes a significant burden through unplanned admission to the ICU, post discharge disability and mortality. Despite widespread implementation of intraoperative lung-protective ventilation strategies over the past decade, results remain inconsistent. Interventions targeting individual parameters like tidal volume or positive end-expiratory pressure (PEEP) have shown equivocal results. The use of high PEEP and recruitment maneuvers raises safety concerns by possible negative hemodynamic effects. Recent studies suggest that individualizing ventilation strategies based on mechanical power-a composite parameter integrating tidal volume, plateau pressure, PEEP, and ventilator frequency-may better predict and help prevent PRF, independently of patients' baseline respiratory system compliance. These studies identified this parameter as interventional targets to reduce lung injury during mechanical ventilation. However, no multicenter randomized controlled trial has been performed in the field of ventilatory settings titration during invasive mechanical ventilation in operating room.
The investigators hypothesize that a ventilation strategy aimed at decreasing mechanical power will reduce the incidence of PRF and mortality in patients undergoing abdominal surgery, compared with a standard strategy using fixed tidal volume and PEEP
Przegląd badań
Status
Szczegółowy opis
Postoperative respiratory failure (PRF) is a dreaded complication that imposes a significant burden through unplanned admission to the intensive care unit (ICU) and post discharge disability. Respiratory failure evident by tracheal intubations 1 month following nonemergent, noncardiac surgeries has been associated with a nine-fold increase in mortality. Efforts to reduce the rates of PRF have incorporated intraoperative ventilation strategies as a central element, with lung-protective ventilation following recommendations for the ICU setting being broadly implemented over the past decade. Interventions targeting individual parameters like tidal volume have shown equivocal results. To summarize, two randomized clinical trials showed lung-protective ventilation with low tidal volume (VT) in addition to high positive end-expiratory pressure (PEEP) and recruitment maneuver (RM) to prevent against postoperative pulmonary complications when compared with ventilation with high VT plus low PEEP without RM. Two other large, randomized trials found no benefit of high PEEP with RM compared with low PEEP without RM in this setting, suggesting that beneficial effects arise primarily from the use of low VT ventilation. Concerns have also been raised about possible negative hemodynamic effects of high PEEP and RMs in these studies. One size does not fit all. Individualized strategies are needed, such as ones using driving pressure (plateau pressure - PEEP), to perform PEEP titration. Using this calculated parameter, reduced incidence of postoperative pulmonary complications has been demonstrated in small randomized controlled trials, and not achieved in others. However, tidal volume and respiratory rate are also important parameters to limit ventilator induced injuries, and are not considered when assessing driving pressure. Mechanical power, a concept that in addition to tidal volume, plateau pressure and positive end-expiratory pressure (PEEP) also integrates the ventilatory frequency, has been recently associated with a higher risk of PRF. This formula is now implemented in the most recent operating room ventilators, and used in routine by some teams, with lack of evidence showing an efficacy of this strategy to set ventilatory settings. Although it has become clear that high mechanical power identifies patients at risk of PRF both in the operating room and ICU, there is an ongoing debate about whether they are linked to PRF, or whether these parameters merely represent an epiphenomenon in patients with impaired respiratory system mechanics and elevated risk at baseline.
Recently, several studies showed that high mechanical power was associated with PRF independent from patients' baseline respiratory system compliance. These studies identified this parameter as interventional targets to reduce lung injury during mechanical ventilation. However, no multicenter randomized controlled trial has been performed in the field of ventilatory settings titration during invasive mechanical ventilation in operating room.
The investigators made the hypothesis that a strategy aimed at decreasing mechanical power (tidal volume, respiratory rate and PEEP individually titrated to minimize the mechanical power) will reduce PRF and mortality in patients undergoing abdominal surgery, when compared with that of a strategy of standard care (with fixed level of tidal volume and PEEP). The investigators expect decreased PRF and mortality rate in the group "mechanical power-guided ventilatory settings". The investigators also expect in this group reduced duration of postoperative mechanical ventilation, reduced incidence of postoperative organ dysfunction, and reduced duration of hospital stay.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Audrey DE JONG, Pr
- Numer telefonu: 04 67 33 72 71
- E-mail: a-de_jong@chu-montpellier.fr
Kopia zapasowa kontaktu do badania
- Nazwa: Samir JABER, Pr
- Numer telefonu: 04 67 33 72 71
- E-mail: s-jaber@chu-montpellier.fr
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adult (≥ 18 years)
- Laparoscopic or non-laparoscopic abdominal surgery
- With an expected duration of at least 2 hours
Exclusion Criteria:
- Patients already receiving mechanical ventilation > 12 hours before surgery;
- Chronic respiratory disease requiring oxygen therapy or mechanical ventilation at home;
- Undrained pneumothorax or subcutaneous emphysema;
- Intracranial hypertension;
- Patients for which death is deemed imminent and inevitable or patients with an underlying disease process with a life expectancy of less than 3 months;
- Patients already enrolled in the IMPROVE III trial;
- Pregnancy in progress or planned during the study period or breastfeeding women (Art. L1121-5 of the French Public Health Code);
- Patients protected by law (Art. L1121-6 to L1121-8 of the French Public Health Code): Individuals deprived of their liberty by judicial or administrative decision, vulnerable persons, minors, adults under guardianship or curatorship;
- Patients not covered by a French social security scheme and not benefiting from such a scheme;
- Absence of free and informed oral consent from the patient before inclusion (except in emergency situation where the patient is unable to provide consent), or absence of written informed consent from his/her proxy if present in an emergency situation (except in life-threatening emergency, where inclusion without consent from the patient or his/her proxy is permitted), in which case consent will be obtained as soon as possible after inclusion.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Mechanical power-guided ventilatory strategy
In the intervention group, ventilatory settings will be personalized according to the mechanical power, after the surgical incision (whether laparoscopy or laparotomy), and after the pneumoperitoneum insufflation (for laparoscopy only) or stop of pneumoperitoneum insufflation.
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During the surgery, adjust RR to maintain EtCO2 between 40-50mmHg, with an inspiratory-to-expiratory time ratio of 1:2 to 1:1, an end-inspiratory pause of 30%, an FiO2 adjusted to maintain SpO2≥94%. Recruitment maneuvers will be performed after intubation, in case of ventilator disconnection, coelioscopy insufflation, change of position, at the end of surgery, or if mechanical power >30%. |
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Aktywny komparator: Control group with standard fixed ventilatory settings
In the control group, standard care will be performed.
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Tidal volume 7 ml/kg predicted body weight, calculated according to a predefined formula: 50+0.91 x (centimeters of height - 152.4) for males and 45.5+0.91 x (centimeters of height - 152.4) for females, fixed PEEP between 6 and 8 cmH20, recruitment maneuvers at the discretion of the physician. The respiratory rate will be adjusted to maintain end-tidal partial pressure of CO2 between 30 and 40 mmHg, a target reported to be used by approximately 90% of physicians according to a recent online survey administered to French anesthesiologists via the French Society of Anesthesia & Intensive Care Medecine (SFAR), which will be published soon, with an inspiratory-to-expiratory time ratio of 1:2 to 1:1, an end-inspiratory pause of 30 %, and an FiO2 adjusted to maintain SpO2 ≥ 94%. Mechanical power will not be measured during the surgery to avoid any modification of the ventilatory setting by the physician in charge. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Composite of postoperative respiratory failure
Ramy czasowe: Up to 12 hours after surgery
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Defined as failure to wean from the ventilator within the first 12 hours after surgery
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Up to 12 hours after surgery
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Composite of postoperative respiratory failure
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Defined as the need for unplanned reintubation following the end of surgery, once extubated
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Composite of postoperative respiratory failure
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Defined as the need for therapeutic non-invasive ventilation following the end of surgery, once extubated
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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All-cause mortality
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Defined as death from any cause occurring within 30 days following surgery.
The time to death will be measured from the date of surgery to the date of death.
Patients discharged from hospital alive before Day 30 or still alive at Day 30 will be considered censored at that time.
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Severity of postoperative pulmonary complications following surgery
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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The severity of pulmonary complications after surgery will be scored on a grade scale ranging from 0 to 4, with grade 0 representing the absence of any pulmonary complication and grades 1 through 4 representing successively the worse forms of pulmonary complications
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Renal dysfunction following surgery
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Postoperative renal dysfunction will be assessed using the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Classification, based on serum creatinine levels and urine output criteria.
The KDIGO classification ranges from Stage 0 to Stage 3, where higher stages indicate more severe renal dysfunction (Stage 0 = no acute kidney injury; Stage 3 = most severe acute kidney injury).
Renal dysfunction will be defined as KDIGO Stage 1 or higher.
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Sepsis and septic shock following surgery
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Will be evaluated after surgery, according to the last recommendations on sepsis and septic shock
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Sepsis-related Organ Failure Assessment (SOFA)
Ramy czasowe: At randomization (day 0), at Day 1, at Day 7
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The SOFA score will be collected at randomization, at Day 1, at Day 7 to evaluate the extent of organ dysfunction.
The score includes six organ systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological function.
Each system is graded from 0 (normal function) to 4 (severe dysfunction) based on objective clinical or laboratory parameters.
The Glasgow Coma Score will be excluded from the calculation
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At randomization (day 0), at Day 1, at Day 7
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Ventilator-free days (VFDs)
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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A ventilator-free day is defined as the receipt as < 2 hours of invasive mechanical ventilation or non-invasive mechanical ventilation (as curative therapy) within a 24-hour period
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Duration of invasive mechanical ventilation
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Measured from the time of initiation of mechanical ventilation to the first tracheal extubation
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Total duration of mechanical ventilation
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Total duration of invasive mechanical ventilation will be measured in days from the initiation of mechanical ventilation until final discontinuation during the follow-up period.
All periods of invasive mechanical ventilation, including episodes requiring reintubation, will be included in the total duration calculation.
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Time to successful tracheal extubation
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Successful extubation reflects both effective weaning from mechanical ventilation and the patient's ability to maintain adequate spontaneous breathing.
it's defined as the interval from the time of initiation of mechanical ventilation to the tracheal extubation that is not followed by reintubation within 7 days
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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ICU-free days
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Are defined as the number of days a patient is both alive and discharged from the intensive care unit (ICU) during the first 30 days following surgery.
Patients who die before ICU discharge will be assigned zero ICU-free days.
The outcome will be censored at 30 days postoperatively or at the time of hospital discharge, whichever occurs first
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Length of ICU stay
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Will be measured from the date of ICU admission to the date of discharge from the ICU.
Patients who are still in ICU on day 30 will be considered censored at that time
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
|
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Length of hospital stay
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Will be measured from the date of hospital admission to the date of discharge from the hospital.
Patients who are transferred to another type of healthcare facility (e.g., rehabilitation center) before Day 30 will be considered as having been discharged from the hospital.
Patients who are still in hospital on day 30 will be considered censored at that time
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Time to death (or censoring)
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Is defined as the time from the date of surgery to the occurrence of death.
Data will be collected up to Day 30, or until the date of hospital discharge, if this occurs before Day 30.
Patients who do not die during this period will be considered censored at that time
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postoperative hypoxemia
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
|
Defined as a PaO₂/FiO₂ ratio ≤ 300 mmHg measured by arterial blood gas analysis performed within 1 hour after extubation, indicating early hypoxemic respiratory failure following surgery
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Postoperative pneumonia
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Defined as a new or progressive pulmonary infiltrate on chest imaging combined with at least one clinical sign (fever, abnormal white blood cell count, purulent secretions, or positive respiratory culture), occurring after surgery, according the European Perioperative Clinical Outcome (EPCO) criteria
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
|
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Acute Respiratory Distress Syndrome (ARDS)
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Defined as acute hypoxemic respiratory failure with bilateral pulmonary opacities not fully explained by cardiac failure or fluid overload, and a PaO₂/FiO₂ ratio ≤ 300 mmHg with PEEP ≥ 5 cmH₂O, under invasive or non-invasive ventilation
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
|
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Total intraoperative intravenous fluid volume
Ramy czasowe: During surgery
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The total volume of crystalloids and colloids (millilitres) during surgery will be recorded
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During surgery
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Total Intraoperative vasopressor dose
Ramy czasowe: During surgery
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The total dose of norepinephrine, epinephrine, phenylephrine, ephedrine during surgery will be recorded.
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During surgery
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Mechanical power
Ramy czasowe: During surgery
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Mechanical power during surgery will be reported in joules/minute (J/min).
If not directly provided by the anesthesia ventilator, it will be calculated using a predefined formula based on recorded ventilatory parameters (tidal volume (ml/kg PBW), respiratory rate, Ppeak (cm H2O), Pplat (cm H2O), PEEP (cm H2O)).
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During surgery
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Tidal volume normalized to predicted body weight
Ramy czasowe: During surgery
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Tidal volume normalized to predicted body weight will be recorded in mL/kg PBW during surgery for the calculation of mechanical power.
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During surgery
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Respiratory rate
Ramy czasowe: During surgery
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Respiratory rate will be recorded in breaths per minute during surgery for the calculation of mechanical power.
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During surgery
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Peak inspiratory pressure (Ppeak)
Ramy czasowe: During surgery
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Peak inspiratory pressure will be recorded in cm H2O during surgery for the calculation of mechanical power.
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During surgery
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Plateau pressure (Pplat)
Ramy czasowe: During surgery
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Plateau pressure will be recorded in cm H2O during surgery for the calculation of mechanical power.
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During surgery
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Positive end-expiratory pressure (PEEP)
Ramy czasowe: During surgery
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Positive end-expiratory pressure will be recorded in cm H2O during surgery for the calculation of mechanical power.
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During surgery
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Ventilation-related adverse events
Ramy czasowe: Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Including presence of hemodynamic instability, pneumothorax and any other life-threatening reason for which the clinician would decide to stop the intervention.
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Up to 30 days after surgery, or by the date of hospital discharge, if this occurs before Day 30
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Rescue therapy for intraoperative hypoxemia
Ramy czasowe: During surgery
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Defined as implementation of any therapy aiming to correct intraoperative hypoxemia such as recruitment maneuvers, a stepwise increase in FiO₂, or increase of the level of PEEP not following the initial recommendations for each group.
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During surgery
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Audrey DEBRUS, Dr, University Hospital, Montpellier
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- RECHMPL24_0492
Informacje o lekach i urządzeniach, dokumenty badawcze
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Badania kliniczne na Operacja brzucha
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University Hospital TuebingenRobert Bosch-Krankenhaus StuttgartRekrutacyjny