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

NCT06692023 | Not Yet Recruiting DMC

• 1 other identifier: BeijingCYH-ICU-008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization to 2 days after randomization

Secondary Outcomes (1)

• Effects of NPPV on sleep quality

  From randomization to 2 days after randomization

Study Arms (2)

High-intensity NPPV

EXPERIMENTAL

Patients will receive high-intensity NPPV

Device: High-intensity NPPV; Device: Low-intensity NPPV

Low-intensity NPPV

ACTIVE COMPARATOR

Patients will receive low-intensity NPPV

Device: High-intensity NPPV; Device: Low-intensity NPPV

Interventions

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.

High-intensity NPPV; Low-intensity NPPV

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.

High-intensity NPPV; Low-intensity NPPV

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Central Study Contacts

Ying ying Zheng, MD

CONTACT

86-10-18601022649; zyy19831016@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: November 18, 2024
• Study Start: December 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)