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Not yet recruiting NCT06692023

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

No phase Interventional Acute Exacerbation of Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-intensity NPPV, Low-intensity NPPV.
Who it may be relevant to
Registry conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 mm
  • 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.

Primary outcome measures

  • NPPV subjective tolerance [Time frame: From randomization to 2 days after randomization]
Secondary outcome measures (1)
  • Effects of NPPV on sleep quality [Time frame: From randomization to 2 days after randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Chao Yang Hospital — Beijing

Identifiers

NCT: NCT06692023 · BeijingCYH-ICU-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗