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Mechanical Power During Pressure Controlled Versus Volume-Controlled Ventilation in Acute Respiratory Failure (MP-PCV-VCV)

18. september 2026 opdateret af: Sahar Ahmed, Assiut University

Mechanical Power During Pressure-Controlled Versus Volume Controlled Mechanical Ventilation in Patients With Acute Respiratory Failure

This prospective observational cohort study aims to compare mechanical power between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) in critically ill adult patients receiving invasive mechanical ventilation. Mechanical power will be assessed at different time points during the first 24 hours after intubation, with the primary comparison performed at 24 hours. The study will also evaluate the association between mechanical power and clinical outcomes, including ICU mortality, hospital mortality, successful weaning, duration of mechanical ventilation, and length of ICU and hospital stay.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

Mechanical ventilation is a life-saving intervention for critically ill patients with acute respiratory failure. However, mechanical ventilation can also contribute to ventilator-induced lung injury when excessive energy is delivered to the respiratory system. Mechanical power, which represents the energy transferred from the ventilator to the respiratory system per unit of time, has emerged as a potentially important parameter for assessing the intensity of mechanical ventilation.

The mode of ventilation may influence mechanical power through changes in airway pressure, tidal volume, respiratory rate, and inspiratory flow. Pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) are commonly used modes of invasive mechanical ventilation, but their effects on mechanical power in critically ill patients may differ.

Therefore, this prospective observational cohort study aims to compare mechanical power between PCV and VCV in critically ill adult patients receiving invasive mechanical ventilation and to evaluate the relationship between mechanical power and relevant clinical outcomes.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

186

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Sahar Ahmed Okily, Master degree of chest disease
  • Telefonnummer: 01094504484 0201094504484
  • E-mail: sara3hmed2012@gmail.com

Undersøgelse Kontakt Backup

Studiesteder

  • Egypten
      • Asyut, Egypten
        • Assuit university

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patients aged >18 years with acute respiratory failure requiring invasive mechanical ventilation and admitted to the Respiratory Intensive Care Unit at Assiut University Hospitals will be enrolled. Eligible patients receiving either pressure-controlled ventilation (PCV) or volume-controlled ventilation (VCV) will be prospectively followed during their ICU and hospital stay.

Beskrivelse

Inclusion Criteria:

  • Adult patients aged >18 years.
  • Patients with acute respiratory failure who are receiving invasive mechanical ventilation.

Exclusion Criteria:

  • Patients whose condition requires shifting between VCV and PCV after enrollment.
  • Patients with neurological, neuromuscular, or muscular disorders.
  • Neurological disorders, e.g., stroke, multiple sclerosis, Parkinsonism, and Guillain-Barré syndrome.
  • Neuromuscular junction disorders, e.g., myasthenia gravis.
  • Muscular disorders, e.g., polymyositis and Duchenne muscular dystrophy.
  • Chest wall abnormalities, e.g., kyphoscoliosis, scoliosis, and pectus excavatum.
  • Tracheostomized patients.
  • Patients with raised intra-abdominal pressure (IAP ≥12 mmHg), as estimated by transvesical manometry e.g., massive ascites, bowel obstruction, and postoperative abdominal surgery.
  • Patients with documented chronic type 2 respiratory failure, characterized by an elevated partial pressure of carbon dioxide (PaCO₂ >45 mmHg), low partial pressure of oxygen (PaO₂), and chronically elevated bicarbonate (HCO₃-) reflecting renal compensation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
93 patients in Pressure controlled ventilation

93 patients in Volume controlled ventilation
93 patients in PCV

93 patients in Volume controlled ventilation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mechanical power
Tidsramme: 24 hours after intubation

Mechanical power will be measured and compared between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV) at 24 hours after intubation.
24 hours after intubation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
mechanical power and ICU mortality, hospital mortality, time to death.
Tidsramme: From hospital admission until 30 days after hospital admission.

Correlation between mechanical power and ICU mortality, hospital mortality, time to death .

  • ICU mortality documented as binary (yes/no) outcome indicating death occurring exclusively during ICU admission.
  • Hospital mortality: documented as binary (yes/no) outcome indicating death occurring during hospitalization, regardless of the location of care at time of death.
  • Time-to-death: documented in days from date of ICU admission till date of event (death).
From hospital admission until 30 days after hospital admission.
Mechanical power over time
Tidsramme: At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.

Changes in mechanical power over time following initiation of invasive mechanical ventilation.
At 1, 6, 12, and 24 hours after initiation of invasive mechanical ventilation.
Successful weaning from mechanical ventilation
Tidsramme: From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)

Correlation between Mechanical power and successful weaning from mechanical ventilation .Successful weaning is defined as successful extubation without the need for re-intubation or noninvasive ventilation (NIV) within the following 48 hours.
From intubation until successful weaning( successful extubation without need for ventilatory support within the following 48 hours)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assiut University

Efterforskere

  • Studieleder: Olfat Mostafa El shinawy, Professor, Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt
  • Studieleder: Sara Mohamed Hashem, Lecteurer, Assiut University, Faculty of Medicine, Chest Diseases Department, Assiut, Egypt

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. oktober 2026

Primær færdiggørelse (Anslået)

30. oktober 2028

Studieafslutning (Anslået)

30. oktober 2029

Datoer for studieregistrering

Først indsendt

13. september 2026

Først indsendt, der opfyldte QC-kriterier

18. september 2026

Først opslået (Faktiske)

22. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • AUN-CH-MP-001

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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