BMI-Adjusted PEEP During One-Lung Ventilation in Thoracic Surgery (SIMPLE-PEEP)
Effect of Body Mass Index-Adjusted Positive End-Expiratory Pressure on Respiratory Mechanics During One-Lung Ventilation in Thoracic Surgery
One-lung ventilation (OLV) is required during many thoracic surgical procedures and is associated with reduced functional residual capacity, atelectasis, ventilation-perfusion mismatch, hypoxemia, and potentially ventilator-induced lung injury. Lung-protective ventilation strategies include low tidal volumes, limitation of airway pressures, and positive end-expiratory pressure (PEEP), but the optimal PEEP level during OLV remains uncertain. Fixed PEEP is simple and reproducible but does not account for individual patient characteristics. Body mass index (BMI) is readily available before anesthesia and is associated with respiratory mechanics, making it a pragmatic candidate for simple PEEP individualization.
SIMPLE-PEEP is a prospective, multicenter, pragmatic, open-label, randomized clinical trial including 150 adults undergoing elective pulmonary resection under general anesthesia requiring OLV. Participants will be randomized to either fixed PEEP of 4 cmH2O or BMI-adjusted PEEP calculated as BMI/3 cmH2O. Other key components of lung-protective ventilation will be standardized between groups.
The primary outcome is driving pressure during the first 20 minutes of OLV, assessed at 5, 10, and 20 minutes after OLV initiation. Secondary outcomes include respiratory system compliance and other respiratory mechanics, estimated mechanical power, oxygenation, intraoperative hypoxemia and rescue maneuvers, hemodynamic safety, vasopressor requirements, and exploratory postoperative respiratory outcomes. No investigational medicinal product, additional invasive procedure, or study-specific advanced monitoring is required.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Jesús M Nieves Alonso, MD
- Telefonszám: +34915202540
- E-mail: jesusmna@gmail.com
Tanulmányi helyek
-
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Catalonia
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Barcelona, Catalonia, Spanyolország, 08036
- Még nincs toborzás
- Hospital Clinic Barcelona
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Kapcsolatba lépni:
- Manuel L López
- E-mail: LOPEZ10@clinic.cat
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Barcelona, Catalonia, Spanyolország, 08041
- Még nincs toborzás
- Hospital de la Santa Creu i Sant Pau
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Kapcsolatba lépni:
- Ana P Parera
- E-mail: AParera@santpau.cat
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Madrid
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Madrid, Madrid, Spanyolország, 28006
- Toborzás
- Hospital Universitario de La Princesa
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Kapcsolatba lépni:
- Jesús M Nieves Alonso, MD
- Telefonszám: +34915202540
- E-mail: jesusmna@gmail.com
-
Madrid, Madrid, Spanyolország, 28007
- Még nincs toborzás
- Hospital General Universitario Geogorio Marañón
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Kapcsolatba lépni:
- Estrela C Caamaño
- E-mail: estrelacaamano@gmail.com
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Age 18 years or older.
- Scheduled thoracic surgery for pulmonary resection requiring general anesthesia and one-lung ventilation.
- Written informed consent obtained before any study-specific procedure.
Exclusion Criteria:
- Simultaneous participation in another interventional clinical trial that could interfere with the protocol.
- Severe hemodynamic instability before the start of the procedure, defined as continuous vasopressor infusion or shock of any etiology.
- Severe restrictive lung disease, defined as total lung capacity <50% of predicted or forced vital capacity <50% of predicted.
- Body mass index >45 kg/m2.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Aktív összehasonlító: Fixed PEEP of 4 cmH2O
|
Fixed PEEP of 4 cmH2O |
|
Kísérleti: BMI-adjusted PEEP calculated as BMI/3 cmH2O
|
BMI-adjusted PEEP calculated as BMI/3 cmH2O |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Driving pressure during the primary T2-T4 window
Időkeret: 20 minutes
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Driving pressure during the primary T2-T4 window, measured at 5, 10, and 20 minutes after initiation of one-lung ventilation and expressed in cmH2O. In conventional volume-controlled ventilation, driving pressure is calculated as plateau pressure minus applied PEEP. In pressure-regulated volume-targeted/volume-guaranteed modes, driving pressure is calculated as total end-inspiratory pressure minus applied PEEP. |
20 minutes
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Respiratory system compliance
Időkeret: At 5, 10, and 20 minutes after initiation of one-lung ventilation; at 60 minutes when applicable; and at the end of one-lung ventilation, all during the surgical procedure on Day 1.
|
Respiratory system compliance will be calculated at each applicable time point as tidal volume divided by driving pressure and expressed in mL/cmH2O |
At 5, 10, and 20 minutes after initiation of one-lung ventilation; at 60 minutes when applicable; and at the end of one-lung ventilation, all during the surgical procedure on Day 1.
|
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Driving pressure at 60 minutes and at the end of one-lung ventilation
Időkeret: At 60 minutes after initiation of one-lung ventilation, when applicable, and at the end of one-lung ventilation.
|
Driving pressure will be assessed at 60 minutes after initiation of one-lung ventilation, when this time point is applicable, and at the actual end of one-lung ventilation, to evaluate the persistence of the physiological effect of the assigned PEEP strategy. |
At 60 minutes after initiation of one-lung ventilation, when applicable, and at the end of one-lung ventilation.
|
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Estimated mechanical power during one-lung ventilation
Időkeret: At 5, 10, and 20 minutes after initiation of one-lung ventilation; at 60 minutes when applicable; and at the end of one-lung ventilation, all during the surgical procedure on Day 1.
|
Ventilatory mechanical power will be estimated from prospectively recorded ventilatory parameters using a prespecified calculation method appropriate to the ventilation mode and expressed in J/min. |
At 5, 10, and 20 minutes after initiation of one-lung ventilation; at 60 minutes when applicable; and at the end of one-lung ventilation, all during the surgical procedure on Day 1.
|
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Incidence of intraoperative hypoxemia during one-lung ventilation
Időkeret: From initiation until completion of one-lung ventilation during the surgical procedure on Day 1 (up to 1 day).
|
Intraoperative hypoxemia will be defined as SpO2 <90% sustained for at least 60 seconds during one-lung ventilation with baseline FiO2 0.6, or any episode of SpO2 <90% requiring immediate clinical intervention at the discretion of the attending anesthesiologist. |
From initiation until completion of one-lung ventilation during the surgical procedure on Day 1 (up to 1 day).
|
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Incidence of major ventilatory rescue
Időkeret: During the first 20 minutes after initiation of one-lung ventilation on Day 1.
|
Major ventilatory rescue during the first 20 minutes after initiation of one-lung ventilation will be defined as any intervention that substantially modifies the assigned ventilatory strategy or respiratory mechanics, including modification of PEEP from the assigned value, recruitment maneuver, CPAP to the non-ventilated lung, temporary restoration of two-lung ventilation, or protocol interruption for safety reasons. |
During the first 20 minutes after initiation of one-lung ventilation on Day 1.
|
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Incidence of intraoperative hypotension
Időkeret: Intraoperative/periprocedural period on Day 1, from induction of anesthesia until the end of surgery.
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Intraoperative hypotension will be defined as mean arterial pressure <65 mmHg sustained for more than 1 minute. |
Intraoperative/periprocedural period on Day 1, from induction of anesthesia until the end of surgery.
|
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Requirement for intraoperative vasopressor support
Időkeret: Time Frame: Intraoperative/periprocedural period on Day 1, from induction of anesthesia until the end of surgery.
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Proportion of participants requiring vasopressor administration during the intraoperative period. Vasopressor use will be recorded as a measure of the hemodynamic safety of the assigned PEEP strategy. |
Time Frame: Intraoperative/periprocedural period on Day 1, from induction of anesthesia until the end of surgery.
|
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Incidence of postoperative pulmonary complications
Időkeret: From the end of surgery until hospital discharge during the index hospitalization (estimated average duration: 3-10 days).
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Occurrence of at least one prespecified postoperative pulmonary complication, including acute respiratory failure, pneumonia, acute respiratory distress syndrome, atelectasis, pneumothorax, bronchopleural fistula, aspiration pneumonitis, pulmonary embolism, pleural empyema, bronchospasm, pleural effusion, or need for postoperative respiratory support or reintubation for respiratory deterioration. This outcome will be considered exploratory. |
From the end of surgery until hospital discharge during the index hospitalization (estimated average duration: 3-10 days).
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- SIMPLE-PEEP
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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