Impact of HI-NPPV Vs LI-NPPV on Tolerance Among AECOPD Patients

ConditionAcute Exacerbation of Chronic Obstructive Pulmonary Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBeijing Chao Yang Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Age <18 years

Excessive respiratory secretions with weak cough

Upper airway obstruction

Recent oral, facial, or cranial trauma or surgery

Trial design

Design model

Crossover

Treatments tested in this trial

High-intensity NPPV
Device
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.
Low-intensity NPPV
Device
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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: High-intensity NPPVExperimental treatment 2 interventions

Group B: Low-intensity NPPVActive comparator 2 interventions

Trial outcomes

Primary outcomes

NPPV subjective tolerance

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.

Time frame

From randomization to 2 days after randomization

Secondary outcomes

Effects of NPPV on sleep quality

The sleep quality is assessed by PSG during night

Time frame

From randomization to 2 days after randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Chao Yang Hospital

Lead sponsor

Source ClinicalTrials.gov

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