Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation
Validation of Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation: A Prospective Physiological Study
The goal of this study is to validate computed inspiratory muscle pressure (cPmus) for monitoring inspiratory effort in adults receiving pressure support ventilation. Researchers will compare cPmus with reference inspiratory muscle pressure calculated using an esophageal balloon catheter, a thin pressure-measuring tube placed in the esophagus. The study will look at how closely the two methods are related and whether they give similar results. Participants will undergo simultaneous monitoring with cPmus and an esophageal balloon catheter. Researchers will adjust pressure support across six levels, recording measurements from both methods at each level.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
This is a prospective validation study with repeated measurements. It aims to validate computed inspiratory muscle pressure (cPmus), a noninvasive estimate of inspiratory muscle pressure provided by the study ventilator (Prunus Padus 9, Shenzhen, China). The reference method is esophageal pressure-derived inspiratory muscle pressure (Pmus). The study will enroll adults receiving invasive pressure support ventilation (PSV).
After obtaining informed consent, participants will undergo simultaneous monitoring with the cPmus algorithm and an esophageal balloon catheter. Pressure support will be adjusted in six levels. Positive end-expiratory pressure (PEEP) will remain unchanged. Each pressure support level will be maintained for 10 minutes. Brief end-expiratory and end-inspiratory occlusion maneuvers will also be performed at each level to obtain additional indices of respiratory drive and inspiratory effort. Esophageal balloon will be removed after completing the last pressure support step.
At each pressure support level, paired values of cPmus and reference Pmus were measured. The corresponding inspiratory pressure-time products, cPTPmus and PTPmus, will also be calculated.
All procedures will follow the study protocol and standardized measurement procedures. Study data will be recorded in case report forms and an electronic database, with checks for completeness, accuracy, and waveform quality.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Jian-Xin Zhou, MD, PhD
- Telefonnummer: 8610 6392 6666
- E-Mail: zhoujx.cn@icloud.com
Studieren Sie die Kontaktsicherung
- Name: Meng-Xue Hou, MD
- E-Mail: himengxue@163.com
Studienorte
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-
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Beijing, China
- Rekrutierung
- Beijing Shijitan Hospital
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Kontakt:
- Jian-Xin Zhou, MD, PhD
- Telefonnummer: 8610 6392 6666
- E-Mail: zhoujx.cn@icloud.com
-
Kontakt:
- Meng-Xue Hou, MD
- E-Mail: himengxue@163.com
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age 18 years or older.
- Receiving pressure support ventilation.
- Written informed consent provided by the participant or a legally authorized representative.
Exclusion Criteria:
- Contraindication to esophageal catheter placement, including uncontrolled coagulopathy, skull base fracture, upper gastrointestinal bleeding, tumor or surgery, neck surgery, or esophagogastric varices.
- Chest trauma, a postoperative state following lung surgery, an active pulmonary air leak (pneumothorax, pneumomediastinum, or bronchopleural fistula), or an indwelling chest drain.
- Neuromuscular disease, diaphragmatic dysfunction, or diaphragmatic surgery.
- Impaired central respiratory drive due to intracranial hypertension or brainstem injury.
- Hemodynamic instability, defined as mean arterial pressure <60 mmHg, systolic blood pressure >180 mmHg, heart rate <40 or >150 beats/min, or norepinephrine dose >1 mcg/kg/min.
- Pregnancy or breastfeeding.
- A decision to withdraw life-sustaining treatment or provide palliative care.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Pressure support 15
Pressure support of 15 cm H2O will be applied for 10 minutes. |
Pressure support of 15 cm H2O will be applied for 10 minutes. |
|
Experimental: Pressure support 13
Pressure support of 13 cm H2O will be applied for 10 minutes. |
Pressure support of 13 cm H2O will be applied for 10 minutes. |
|
Experimental: Pressure support 11
Pressure support of 11 cm H2O will be applied for 10 minutes. |
Pressure support of 11 cm H2O will be applied for 10 minutes. |
|
Experimental: Pressure support 9
Pressure support of 9 cm H2O will be applied for 10 minutes. |
Pressure support of 9 cm H2O will be applied for 10 minutes. |
|
Experimental: Pressure support 7
Pressure support of 7 cm H2O will be applied for 10 minutes. |
Pressure support of 7 cm H2O will be applied for 10 minutes. |
|
Experimental: Pressure support 5
Pressure support of 5 cm H2O will be applied for 10 minutes. |
Pressure support of 5 cm H2O will be applied for 10 minutes. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Computed inspiratory muscle pressure (cPmus)
Zeitfenster: 2 hours
|
Computed inspiratory muscle pressure (cPmus) will be measured. |
2 hours
|
|
Inspiratory muscle pressure (Pmus)
Zeitfenster: 2 hours
|
Inspiratory muscle pressure (Pmus) will be measured. |
2 hours
|
|
Computed inspiratory muscle pressure-time product (cPTPmus)
Zeitfenster: 2 hours
|
Computed inspiratory muscle pressure-time product (cPTPmus) will be measured. |
2 hours
|
|
Inspiratory muscle pressure-time product (PTPmus)
Zeitfenster: 2 hours
|
Inspiratory muscle pressure-time product (PTPmus) will be measured. |
2 hours
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Occluded airway pressure at 100ms (P0.1)
Zeitfenster: 2 hours
|
Occluded airway pressure at 100ms (P0.1) will be measured. |
2 hours
|
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Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)
Zeitfenster: 2 hours
|
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc) will be measured. |
2 hours
|
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Pressure muscle index (PMI)
Zeitfenster: 2 hours
|
Pressure muscle index (PMI) will be measured. |
2 hours
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jian-Xin Zhou, Capital Medical University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- IIT2026-032-002
Plan für individuelle Teilnehmerdaten (IPD)
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