Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Conditions
Brief summary
To determine whether high-intensity NPPV, compared with low-intensity NPPV, could have an effect on the subjective tolerance in patients with an AECOPD and hypercapnia.
Detailed description
To evaluate the subjective tolerance of high-intensity NPPV and low-intensity NPPV patients in a conscious state by two questionnaire surveys; To assess tolerance of high-intensity NPPV and low-intensity NPPV patients patient in sleeping status by PSG monitoring.
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
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double
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 |
|---|---|---|
| NPPV subjective tolerance | From randomization to 2 days after randomization | NPPV subjective tolerance is mainly evaluated through two questionnaire surveys. Questionnaire survey 1 includes 19 questions, including bloating , appetite, thirst, dryness of the mouth and nose, conjunctivitis, facial tenderness, fear, airflow shock, mask tolerance, ear pain, noise, overall tolerance of NPPV, willingness to use NPPV, confidence of using NPPV, breathless relief score, sleep quality, drowsiness in day, physical strength, and mood. Questionnaire survey 2 mainly evaluates patients' feelings of using NPPV under different emotional states, feelings of using NPPV under different physical states, and feelings of using NPPV in daily life states. Each question is scored from 0 to 100 points. The higher scores indicate better positive feedback. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of NPPV on sleep quality | From randomization to 2 days after randomization | The sleep quality is assessed by PSG during night |
Countries
China
Contacts
Primary ContactYing ying Zheng, MD
Outcome results
None listed