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

Impact of High-Intensity-NIV Vs Low-intensity-NIV on Subjective Tolerance Amomg Patients with AECOPD : a Randomised Cross-over Pilot Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: High-intensity NPPV; Device: Low-intensity NPPV

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying ying Zheng, MD; Phone Number: 86-10-18601022649; Email: zyy19831016@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing Chao Yang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-intensity NPPV; Patients will receive high-intensity NPPV	Device: High-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.; Device: Low-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.
Active Comparator: Low-intensity NPPV; Patients will receive low-intensity NPPV	Device: High-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.; Device: Low-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of NPPV on sleep quality	The sleep quality is assessed by PSG during night	From randomization to 2 days after randomization

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: BeijingCYH-ICU-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No