Impact of High-Intensity-NIV Vs Low-intensity-NIV on Subjective Tolerance Amomg Patients with AECOPD : a Randomised Cross-over Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- NPPV subjective tolerance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
NPPV subjective tolerance
Time Frame: 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 Outcomes
- Effects of NPPV on sleep quality(From randomization to 2 days after randomization)