Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
To determine whether high-intensity NPPV, compared with low-intensity NPPV, could reduce the need for endotracheal intubation during hospitalization in patients with an AECOPD and hypercapnia.
Interventions
DEVICEHigh-intensity NPPV
In the high-intensity NPPV group, IPAP is initially adjusted in increments/decrements of 1-2 cmH2O, typically ranging from 20 to 30 cmH2O (or a tolerated maximum), to obtain a VT 10-15 mL/kg PBW and a respiratory rate \<25 breaths/min. Subsequent adjustments to IPAP are based on the results of arterial blood gases (ABGs; up to 30 cmH2O) to achieve normocapnia (if possible), or to maximally decrease PaCO2 toward normocapnia if normocapnia can not be achieved. If PaCO2 decreases to less than 35 mmHg, IPAP will be decreased to achieve normocapnia.
DEVICELow-intensity NPPV
In the low-intensity NPPV group, as well as during the 6-hour trial of low-intensity NPPV, IPAP is initially adjusted in increments/decrements of 1-2 cmH2O (up to 20 cmH2O), according to patients' tolerance, to obtain a VT 6-10 mL/kg PBW and a respiratory rate \<25 breaths/min. Subsequent adjustments to IPAP are based on the results of ABGs (up to 20 cmH2O) to achieve a pH of ≥7.35 and to reduce PaCO2 to a level deemed appropriate by the attending physician.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AECOPD confirmed by the 2019 criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) * Arterial pH \<7.35 and PaCO2 \>45 mmHg at screening entry * PaCO2 \>45 mmHg after a 6-hour trial of low-intensity NPPV
Exclusion criteria
* Age \<18 years * Excessive respiratory secretions with weak cough * Upper airway obstruction * Recent oral, facial, or cranial trauma or surgery * Recent gastric or esophageal surgery * Presence of restrictive ventilatory dysfunction (eg, consolidation or removal of at least one pulmonary lobe, massive pleural effusion, chest wall deformity, continuous strapping with thoracic or abdominal bandage, or severe abdominal distension) * Active upper gastrointestinal bleeding * Cardiac or respiratory arrest * Arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) \<100 mmHg * Pneumothorax * Obvious emphysematous bullae confirmed by chest CT scan * Ventricular arrhythmia or myocardial ischemia * Severe hemodynamic instability (mean arterial pressure \<65 mmHg) * Severe metabolic acidosis (pH \<7.20 and bicarbonate \<22 mmol/L) * Refusal to receive NPPV or give informed consent * Prior endotracheal intubation or tracheostomy during the current hospitalization * A do-not-intubate order
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The need for endotracheal intubation during hospitalization | From randomization to discharge from hospital | Defined as the proportion of patients who needed for endotracheal intubation during hospitalization after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for endotracheal intubation at day 28 | Within 28 days since randomization | Defined as the proportion of patients who needed endotracheal intubation within 28 days since randomization |
| Actual intubation at day 28 | Within 28 days since randomization | Defined as the proportion of patients receiving intubation and invasive ventilation within 28 days after randomization |
| The composite of actual intubation or avoiding intubation by crossover to high-intensity NPPV | From randomization to discharge from hospital | Defined as the incidence of patients receiving actual intubation in the high-intensity NPPV group vs the composite incidence of actual intubation or avoiding intubation by crossover to high-intensity NPPV in case of intubation criteria in the low-intensity NPPV group) during hospitalization after randomization |
| NPPV weaning success | From randomization to discharge from hospital | Defined as the proportion of patients with persistent disconnection of NPPV without the presence of respiratory distress within the following 72 hours during hospitalization after randomization |
| Mortality in hospital | From randomization to discharge from hospital | — |
| Mortality at day 28 | Within 28 days since randomization | — |
| Mortality at day 90 | Within 90 days since randomization | — |
| Actual intubation during hospitalization | From randomization to discharge from hospital | Defined as the proportion of patients actually receiving intubation and invasive ventilation during hospitalization after randomization |
| Live discharge from the hospital | From randomization to discharge from hospital | Defined as the proportion of patients with the exception of those who died and withdrawn treatment therapy during hospitalization after randomization. |
| Length of hospital stay | From hospital admission to discharge | Defined as the number of days for the index hospitalization |
| Length of hospital stay after randomization | From randomization to discharge from hospital | Defined as the number of hospitalization days since randomization |
| Invasive ventilator-free days at day 28 | Within 28 days since randomization | Defined as 28 minus the number of days with invasive ventilator (range, 0-28 days) since randomization |
| ICU-free days at day 28 | Within 28 days since randomization | Defined as 28 minus the number of days in the ICU (range, 0-28 days) since randomization |
| Hospital readmission at day 90 | Within 90 days since randomization | Defined as the number of hospitalization days within 90 days since randomization |
| Intensive care unit admission | From randomization to discharge from hospital | Defined as the proportion of patients who transferred to ICU during hospitalization after randomization |
Countries
China
Outcome results
None listed