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NCT06160687Befejeződött

PSV Versus ASV With Intellisync Mode for Delivery of NIV in AECOPD

Randomised Control Trial to Study the Role of Non-invasive Ventilation Using Pressure Support Ventilation Versus Adaptive Support Ventilation With Intellisync Mode in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 23.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

Acute exacerbation of chronic obstructive pulmonary disease (COPD) is defined acute worsening of respiratory symptoms requiring additional therapy. COPD exacerbations affects the health status and quality of life of affected patients. The inpatient mortality during exacerbation is 3 to 4% while, intensive care unit (ICU) mortality approaches 43 to 46%. Each episode of exacerbation increases the risk of mortality subsequently(1) Non-invasive ventilation (NIV) therapy has established role in mild to moderate exacerbations of COPD. But the use of NIV therapy outside of acute exacerbation is uncertain(2) NIV use has been shown to prevent endotracheal intubation and improved hospital and ICU survival. NIV decreases the work of breathing by unloading the respiratory muscles through assisting the inspiratory phases and counterbalancing the intrinistic positive end expiratory positive pressure (ipeep)(3). NIV is delivered through face mask, although newer interfaces like helmet available(3). Tradionally pressure targeted mode is used in NIV therapy and is often given intermittently rather than continuously(4). NIV therapy via face mask was first used by Meduri et. Al in acute respiratory failure patients. Subsequent multiple randomized control trials established the role of NIV therapy in better gas exchange, reducing PCO2, reducing endotracheal intubation thereby reducing mortality, length of stay in hospital(3). NIV-PSV (pressure support ventilation) consists of 2 pressures. IPAP (inspiratory positive airway pressure) and EPAP (expiratory positive airway pressure) or PEEP. Pressure support is usually the pressure added above PEEP. Pressure support is usually started with 8-10 cm H2O to obtain a tidal volume of 6-8ml/kg ideal body weight. EPAP/PEEP is adjusted to counterbalance the iPEEP. It is usually kept at 4-6cm H2O. Fio2 is kept to maintain saturation of 88-92%. Inspiratory trigger is usually set at 1 L/min. Expiratory trigger kept at 50%. Back up rate should always be kept usually lower than the patient respiratory rate 10-12 breaths/min(5). Adaptive support ventilation (ASV) is a new method of closed loop ventilation which can switch back between pressure support and pressure control modes of ventilation. Based on the ideal body weight and % of minute volume ventilation given, the ASV mode choses the best tidal volume and respiratory rate according to the patient lung mechanics by calculating expiratory time constant (RCe) through expiratory flow volume curve(6). Since closed loop system, being a completely automated system, prevent frequent adjustment by clinician and thereby increasing the time and capacity of medical staff. The first application of such closed loop system in mechanical ventilation was done by saxton in1953 in iron lung for regulation of etCO2(7). Studies published on ASV as non-invasive mode of ventilation is limited. In a feasibility study, it has been shown that ASV can be used in non-invasive mode of ventilation with similar results to PSV in COPD patients(8).

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
55 (tényleges)
Első benyújtás
2023. nov. 29.
Kezdés
2023. dec. 1.
Elsődleges befejezés
2025. ápr. 30.
Fő szponzor
Post Graduate Institute of Medical Education and Research, Chandigarh
NCT-szám
NCT06160687

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Bevont résztvevők: 55
  • 2023. dec. 1. és az elsődleges befejezés (2025. ápr. 30.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

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Korábbi kezelés

  • Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality).

Más betegség

  • Non-COPD acute hyper-capneic respiratory failure.
  • Severe impairment of consciousness (Glasgow coma scale score <8).
  • Patient already on home NIV therapy for chronic respiratory failure.
  • Failure to provide informed consent.

Egyéb

  • Patients with any one of the following criteria will be excluded from the current study:
  • Hypotension (systolic blood pressure <90 mmHg).
  • Inability to clear respiratory secretions.
  • Subjects who have an artificial airway like tracheostomy tube or T-tube.

Kiket keres a vizsgálat

  • Consecutive subjects with AECOPD will be eligible for inclusion in the study if they meet all the following:
  • an acute (<7 days) sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity or character, dyspnea) beyond the normal day-to-day variation;
  • arterial blood gas analysis showing a PaCO2 >45 mm Hg with either pH between 7.25 and 7.35 or respiratory rate (18) >30 breaths/minute; and,
  • exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.

Életkor a regiszterben: 13 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

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HelyszínVárosOrszágHelyszín állapota
Respiratory ICU, Department of Pulmonary Medicine, PGIMERChandigarhIndiaIsmeretlen állapot

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