Effects of LPG and Ventilation Interventions on Reducing HAP and Improving Cardiopulmonary Health
- Conditions
- Cardiopulmonary FunctionEnvironmental Exposures
- Registration Number
- NCT07005193
- Lead Sponsor
- Huazhong University of Science and Technology
- Brief Summary
The goal of this clinical trial is to evaluate the independent and synergistic effects of liquefied petroleum gas (LPG) substitution and improved ventilation on household air pollution (HAP) reduction and cardiopulmonary health. The main questions it aims to answer are:
1. Does LPG substitution or improved ventilation reduce HAP and improve cardiopulmonary health?
2. Would the combined intervention of LPG substitution and improved ventilation outperform single interventions?
3. What is the cost-effectiveness of such interventions, and are they sustainable?
Participants will be randomized in 4 groups:
A: Solid fuel + no ventilation facilities group (150 households): Continued use of solid fuels without ventilation facilities, with a one-time financial compensation provided post-intervention; B: Liquefied petroleum gas (LPG) + no ventilation facilities group (150 households): Provided with LPG stoves and instructed to use them for cooking, with regular LPG supply during the intervention period; C: Solid fuel + ventilation facilities group (150 households): Maintained solid fuel usage habits while provided with ventilation facilities and instructed to use them during cooking, with electricity costs compensated during the intervention; D: LPG + ventilation facilities group (150 households): Provided with both LPG stoves and ventilation facilities, instructed to use both during cooking, with regular LPG supply and electricity cost compensation throughout the intervention period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
- Clinical diagnosis of major chronic diseases such as severe respiratory diseases, cardiovascular diseases, malignant tumors, or end-stage renal disease;
- Pregnant or breastfeeding women;
- Current smokers or individuals with self-reported exposure to productive dust or other occupational hazards;
- Individuals who are unable to fully understand the study process or clearly express their own complaints, such as those with psychiatric disorders or severe neuroses, or who cannot cooperate with the study for other reasons.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Change in the Number of Ultrafine particles (UFP) 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: particles/cm³, Measuring instrument: TSI NanoScan (TSI, USA), MicroPEM (PennEngineering, USA), Gillian5000 (Sensidyne, USA), Measurement method: Monitoring device sensors.
Change in the Concentrations of PM2.5 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: ug/m3, Measuring instrument: TSI NanoScan (TSI, USA), MicroPEM (PennEngineering, USA), Gillian5000 (Sensidyne, USA), Bbair (Yuanrui Environmental Protection Technology Co., Ltd, China) , Measurement method: Monitoring device sensors.
Change in the Heart Rate Variability (HRV) Measured by 12-lead ECG 1 year, with follow-ups at 6, 12, 24, and 36 months Heart rate variability measured using standard 12-lead electrocardiogram (ECG). Measuring instrument: HeaLink heart rate sensor (Henan Link Medical Technology Co., Ltd., China), The time-domain indicators include:SDNN: Standard deviation of all normal-to-normal (NN) intervals over 24 hours / SDANN: Standard deviation of the average NN intervals calculated over 5-minute segments throughout 24 hours / RMSSD: Root mean square of successive differences between adjacent NN intervals over 24 hours.
The frequency-domain indicators include: TP: Total power / LF: Low-frequency power / HF: High-frequency power / LF/HF: Ratio of low-frequency to high-frequency power.Change in the Forced Vital Capacity (FVC) 1 year, with follow-ups at 6, 12, 24, and 36 months Forced Vital Capacity measured using spirometer (HI105; Chestgraph, Japan). Units of Measure: Liters. Method of Measurement: Standardized spirometric testing protocol.
Change in the Forced Expiratory Volume in 1 Second (FEV1) 1 year, with follow-ups at 6, 12, 24, and 36 months Forced Expiratory Volume in 1 Second measured using spirometer (HI105; Chestgraph, Japan). Units of Measure: Liters. Method of Measurement: Standardized spirometric testing protocol.
- Secondary Outcome Measures
Name Time Method Change in the Systolic and Diastolic Blood Pressure 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: mmHg, Instrument: Omron (Japan);
Change in the Fractional Exhaled Nitric Oxide (FeNO) 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: ppb , Instrument: NIOX VERO (Aerocrine AB; Solna, Sweden);
Change in the Pulse Wave Velocity (PWV) 1 year, with follow-ups at 6, 12, 24, and 36 months Assessed using an arterial stiffness analyzer (Itamar Medical, Israel) to measure arterial stiffness in meters per second (m/s).
Change in the Concentrations of Black Carbon (BC) 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: ug/m3, Measuring instrument: Model AE51 (AethLabs, USA), Measurement method: Monitoring device sensors.
Change in the Concentrations of PM1 / PM10 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: ug/m3, Measuring instrument: TSI NanoScan (TSI, USA), MicroPEM (PennEngineering, USA), Gillian5000 (Sensidyne, USA), Bbair (Yuanrui Environmental Protection Technology Co., Ltd, China) , Measurement method: Monitoring device sensors.
Change in the Concentrations of Specific Chemical Components in Particulate Matter 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: ug/m3, Measuring instrument: Gilian (Sensidyne, USA), PEM-2-2.5 (MSP,USA), Measurement method: ICP-MS (Inductively Coupled Plasma Mass Spectrometry) and GC-MS/MS (Gas Chromatography-Tandem Mass Spectrometry).
Change in the Concentrations of Ozone (O₃) 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: ug/m3, Measuring instrument: AEROQUAL Series 500 (Aeroqual, New Zealand), Measurement method: Monitoring device sensors.
Change in the Forced Expiratory Flow at 75% of FVC (FEF75) 1 year, with follow-ups at 6, 12, 24, and 36 months Forced Expiratory Flow at 75% of Forced Vital Capacity measured in Liters/Second. Units of Measure: Liters/Second. Method of Measurement: Standardized spirometric testing protocol.
Change in the Forced Expiratory Flow at 50% of FVC (FEF50) 1 year, with follow-ups at 6, 12, 24, and 36 months Forced Expiratory Flow at 50% of Forced Vital Capacity measured in Liters/Second. Units of Measure: Liters/Second. Method of Measurement: Standardized spirometric testing protocol.
Change in the Forced Expiratory Flow at 25% of FVC (FEF25) 1 year, with follow-ups at 6, 1 protocol.2, 24, and 36 months Forced Expiratory Flow at 25% of Forced Vital Capacity measured in Liters/Second. Method of Measurement: Standardized spirometric testing
Change in the Peak Expiratory Flow (PEF) 1 year, with follow-ups at 6, 12, 24, and 36 months Peak Expiratory Flow measured using spirometer (HI105; Chestgraph, Japan).Units of Measure: Liters/Second. Method of Measurement: Standardized spirometric testing protocol.
Change in the Cardio-Ankle Vascular Index (CAVI) 1 year, with follow-ups at 6, 12, 24, and 36 months Measured using arterial stiffness analyzer (Itamar Medical, Israel) to assess arterial stiffness.
Change in the Peripheral Arterial Tone (PAT) Index 1 year, with follow-ups at 6, 12, 24, and 36 months Assessed using the EndoPAT noninvasive endothelial function detection system (Itamar Medical, Israel).
Change in the Environmental Noise Level 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: dB, Measuring instrument: Model ASV5910+ (Aihua Instruments Co., Ltd, China) , Measurement method: Monitoring device sensors.
Change in the Concentrations of Internal Exposure to PAHs and VOCs 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: ng/mL, Measuring samples: Urine samples, Measurement method: GC-MS/MS.
Change in the Concentrations of Internal Exposure to Metal Elements 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: ng/mL, Measuring samples: Blood and urine samples, Measurement method: ICP-MS.
Change in the Concentrations of Total Volatile Organic Compounds (TVOCs) 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: ug/m3, Measuring instrument: Model TG-503 (GrayWolf, USA), Measurement method: Monitoring device sensors
Change in the Concentrations of Nitrogen Dioxide (NO₂) 1 year, with follow-ups at 6, 12, 24, and 36 months Unit: ug/m3, Measuring instrument: AEROQUAL Series 500 (Aeroqual, New Zealand) , Measurement method: Monitoring device sensors.