Impact of HI-NPPV Vs LI-NPPV on Tolerance Among AECOPD Patients (NCT06692023) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of HI-NPPV Vs LI-NPPV on Tolerance Among AECOPD Patients
China20 participantsStarted 2024-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NPPV subjective tolerance
Timeframe: From randomization to 2 days after randomization