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Inkrementell och dekrementell peep -titrering av olika strategier i ämnen med ARDS: En prospektiv fysiologisk studie (ARDS，PEEP)

21 augusti 2026 uppdaterad av: Zhou Yongfang, West China Hospital

Forskning om precision individualiserade mekaniska ventilationsstrategier för ARDS styrd av elektrisk impedansomografiövervakning och utvärdering av skillnaderna i ventilation och perfusionsfördelning

Utredarna genomförde en prospektiv fysiologisk observationsstudie på ARDS -befolkning, beskrev sina fysiologiska och EIT -index med olika PEEP -titreringsmetoder och jämförde och analyserade också dessa index för att avgöra om det fanns skillnader mellan olika PEEP -titreringsmetoder. Syftet med denna studie var till Utforska och avslöja de fysiologiska skillnaderna som svar på optimal PEEP på olika sätt ， och analyserade korrelationen mellan den optimala Peep på dessa olika sätt.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Faktisk)

31

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital of Sichuan University, Chengdu

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

NTUBATED och mekaniska ventilerade patienter under 18 år med måttlig-svaverande ARDS (PAO2 /FIO2, 200 mm Hg) som antogs till ICU inom 48 timmar registrerades från oktober 2022 till juli 2024.

Beskrivning

Inkluderingskriterier:

  • Intuberade och mekaniska ventilerade patienter i ICU inom 48 timmar
  • Vara över 18 år
  • Med måttlig-severe ARDS (PAO2 /FIO2, 200 mm Hg)

Uteslutningskriterier:

  • Allvarliga kroniska obstruktiva lungsjukdomar
  • Lungbulla (> 1 cm) eller pneumotorax eller pneumomediastinum eller subkutant emfysem
  • Graviditet
  • BMI ≥35 kg/m2
  • Misstänkt lungvaskulär blödning
  • Medvetenhetsstörning eller intrakraniell hypertoni
  • Svår hjärtdysfunktion (New York Heart Association klass III eller IV, akut -koronarsyndrom eller ihållande ventrikulär takyarrytmi), kardiogen chock eller efter större hjärtkirurgi
  • Hemodynamisk instabilitet (dvs medelvärde arteriellt tryck [MAP] <60 mm Hg trots vasopressoranvändning
  • Det medicinska teamet överväger korta perioder med högt tryck för att vara osäkra
  • Kontraindikationer för placering av esophageala tryckkatetrar (t.ex. esophageal varix eller fraktur av skalle bas)
  • Kontraindikationer för EIT -övervakning (inklusive pacemaker eller kutan sjukdomar som begränsar elektrodplacering)
  • Agonala stadium eller slutstadier av sjukdomar

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
the selected PEEP values
Tidsram: through study completion, an average of 1 year

1. Method-specific selected PEEP values

  • Description: The principal endpoint was the set of 15 method-specific selected PEEP values determined for each patient.
  • Unit of Measure: cmH₂O
through study completion, an average of 1 year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
SpO2/FiO2 at each selected PEEP
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
SpO2/FiO2 measured at each selected PEEP. This study will separately measure peripheral oxygen saturation (SpO₂, unit: %) and fraction of inspired oxygen (FiO₂, unit: %). Because both measurements share the same unit (%), they will not be reported as separate outcome measures. Instead, they will be aggregated into a single reported value: the SpO₂/FiO₂ ratio (dimensionless). At each selected positive end-expiratory pressure (PEEP) level, the ratio will be calculated as S/F = SpO₂ (%) ÷ FiO₂ (%), and this ratio will be recorded as the final outcome measure.
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
respiratory system compliance value at each selected PEEP
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
This study will directly record the respiratory system compliance value as measured and displayed by the ventilator (unit: mL/cmH₂O) at each selected PEEP.
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
plateau pressure at each selected PEEP
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
At each selected positive end-expiratory pressure (PEEP) level, plateau pressure will be directly recorded from the ventilator after performing an inspiratory hold maneuver. This value is displayed by the ventilator in cmH₂O
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Driving Pressure at each selected PEEP
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
At each selected positive end-expiratory pressure (PEEP) level, plateau pressure (Pplat, unit: cmH₂O) will be measured via the ventilator, and the corresponding PEEP value (unit: cmH₂O) will be recorded. Driving pressure (ΔP) is calculated as the difference between the two: ΔP = Pplat - PEEP (unit: cmH₂O).
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
End-inspiratory Transpulmonary Pressure (PTPi) at each selected PEEP
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
After placement of an esophageal pressure catheter, the ventilator will monitor esophageal pressure (Pes) and airway pressure. At each selected positive end-expiratory pressure (PEEP) level, an end-inspiratory hold maneuver will be performed. The end-inspiratory transpulmonary pressure (PTPi) is calculated as the difference between the airway plateau pressure (Pplat) measured during the hold and the corresponding esophageal pressure (Pes): PTPi = Pplat - Pes (unit: cmH₂O).
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
End-expiratory Transpulmonary Pressure (PTPe) at each selected PEEP
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
After placement of an esophageal pressure catheter, the ventilator will monitor esophageal pressure (Pes) and airway pressure. At each selected positive end-expiratory pressure (PEEP) level, an end-expiratory hold maneuver will be performed. The end-inspiratory transpulmonary pressure (PTPe) is calculated as the difference between the PEEP measured during the hold and the corresponding esophageal pressure (Pes): PTPe = PEEP - Pes (unit: cmH₂O). This calculated value is the single reported outcome measure
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
transpulmonary driving pressure at each selected PEEP
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
After placement of an esophageal pressure catheter, the ventilator will monitor transpulmonary pressures. At each selected PEEP level, end-inspiratory transpulmonary pressure (PTPi) and end-expiratory transpulmonary pressure (PTPe) are obtained during inspiratory and expiratory hold maneuvers, respectively. Both are measured in cmH₂O. Transpulmonary driving pressure is calculated as the difference: ΔPtp = PTPi - PTPe (unit: cmH₂O).
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
EIT-derived Regional Ventilation Parameters at each selected PEEP level
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Using electrical impedance tomography (EIT), the lung is divided into four regions of interest (ROI I to ROI IV) from ventral to dorsal. For each ROI, the percentage of tidal impedance variation relative to total tidal impedance variation is recorded (% of total). unit: cmH₂O
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
the center of ventilation (COV) at each selected PEEP level
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
the center of ventilation (COV) is calculated as the position of the ventilation center along the ventral-dorsal axis, expressed as a percentage (0% = ventral, 100% = dorsal). this parameter is measured in %
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
CL HP% (overdistension region) at each selected PEEP level
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Using electrical impedance tomography (EIT)，based on regional compliance analysis，CL HP% represent the percentage of lung regions showing a decrease in compliance at high PEEP due to overdistension (unit: %).
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
CL LP% (collapse region) at selected PEEP
Tidsram: baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process
Using electrical impedance tomography (EIT)，based on regional compliance analysis，CL LP% represent the percentage of lung regions showing a decrease in compliance at low PEEP due to collapse (unit: %).
baseline, within 5 minutes after the PV-tool measurement, and within 5 minutes after each increment and decrement of PEEP during the PEEP adjustment process

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

West China Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 december 2024

Primärt slutförande (Faktisk)

28 juli 2025

Avslutad studie (Faktisk)

28 juli 2025

Studieregistreringsdatum

Först inskickad

5 december 2024

Först inskickad som uppfyllde QC-kriterierna

29 januari 2025

Första postat (Faktisk)

5 februari 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • PEEP Titration
  • 2024YFFK0329 (Annat bidrag/finansieringsnummer: Sichuan Science and Technology Program)
  • 2024ZD0530000 (Annat bidrag/finansieringsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project)

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NEJ

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