ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT07060833 (Bubble CPAP) के लिए अकाल शिशु वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ
मैकगिल विश्वविद्यालयAcoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure (Bubble CPAP) 30 अवलोकनात्मक
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07060833 (Bubble CPAP) एक अवलोकनात्मक चिकित्सकीय अध्ययन है जो अकाल शिशु से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 3 अप्रैल 2025 को हुई थी, और इसमें कुल 30 प्रतिभागियों के नामांकन की योजना है। मैकगिल विश्वविद्यालय इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 मार्च 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 11 जुलाई 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
This is an observational, proof-of-concept, feasibility study where 30 preterm infants on bubble CPAP with gestational age < 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital.
The study's main goals are:
- To determine the relationship between ambient bubbling sounds and delivered pressures in preterm infants on bCPAP.
- To determine the relationship be...
विस्तृत विवरण
Continuous positive airway pressure (CPAP) is an essential, non-invasive therapy for treating various respiratory conditions in the Neonatal Intensive Care Units (NICU). CPAP is an effective treatment for respiratory distress syndrome, apneas, or after extubation, exerting its physiological benefits by maintaining upper airway patency and functional residual capacity. Bubble CPAP (bCPAP) is the most widely used CPAP ...और दिखाएँ
आधिकारिक शीर्षक
The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery
स्वास्थ्य स्थितियां
अकाल शिशुअन्य अध्ययन आईडी
- Bubble CPAP
- 2025-10708
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-04-03
अंतिम अद्यतन प्रकाशित
2025-07-11
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-03
नामांकन (अनुमानित)
30
अध्ययन प्रकार
अवलोकनात्मक
स्थिति
भर्ती जारी
प्रमुख शब्द
Bubble CPAP
Airflow
Neonatal Intensive Care
Respiratory acoustics
Acoustic monitoring
Airway pressure monitoring
Bubbling sounds
Airflow
Neonatal Intensive Care
Respiratory acoustics
Acoustic monitoring
Airway pressure monitoring
Bubbling sounds
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
Phase I: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP) Group 1 will consist of 15 preterm infants on bCPAP in whom the external bubble CPAP sounds and the pressures from the CPAP system itself will be recorded for 3 hours. To do so, we will use a standard microphone placed on the water tank and an external pressure transducer inserted into the expiratory limb of the bubble CPAP circuit. | External pressure transducer The delivered CPAP pressure will be measured using an ultra-thin, multi-use catheter pressure transducer inserted into a port in the expiratory limb of the bubble CPAP circuit. Standard microphone The bubble sound of the water tank will be collected with a standard condenser microphone directly affixed to the pole holding the water tank, with a secure clip. |
Phase II: 15 preterm infants on Bubble Continuous Positive Airway Pressure (bCPAP) Group 2 will consist of 15 preterm infants on bCPAP in whom the external bubble CPAP sounds and the pressures from the CPAP system itself will be recorded. To do so, we will use a standard microphone placed on the water tank and a pressure transducer inserted into the expiratory limb of the bubble CPAP circuit. In addition, the internal bubble CPAP sound and pressure transmitted to the infant's lungs will be measured...और दिखाएँ | External pressure transducer The delivered CPAP pressure will be measured using an ultra-thin, multi-use catheter pressure transducer inserted into a port in the expiratory limb of the bubble CPAP circuit. Standard microphone The bubble sound of the water tank will be collected with a standard condenser microphone directly affixed to the pole holding the water tank, with a secure clip. Wireless acoustic sensor The wireless acoustic sensor contains a dual microphone capable of capturing target sounds as well as ambient noise. The frequencies associated with ambient noise will be subtracted to maximize the signal-to-noise ratio of the bubble sound waveform. The wireless sensor will be placed on the suprasternal notch of the infant for monitoring the bubble sounds transmitted to the lungs and secured using a silicone-based ta...और दिखाएँ Internal pressure transducer The transmitted CPAP pressure will be measured using an ultra-thin, single-use catheter pressure transducer inserted through the mouth to the level of the infant's nasopharynx. The data will be acquired with a sampling rate of 10kHz and stored for later analysis. |
प्राथमिक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Pressure | The mean pressure and the standard deviation of the pressure will be computed for each segment. | 3 hours |
External bubble CPAP sounds | Two metrics will be computed:
1. The root mean square (RMS)
2. The power contained between a pre-determined range within each segment; We will determine the range that contains 80% of the signal power, in order to minimize other noises from bubble CPAP signal. | 3 hours |
Internal bubble CPAP sounds | 1. We will apply biomedical signal processing methods to separate the bubbling sounds from breathing sounds. Then, RMS and power will be computed.
2. We will use the Pearson correlation coefficient to compute the relationship between bubbling sound and pressure metrics. We will evaluate the linear regression models to identify the combination of sound metrics and covariates with the highest predictive accuracy. | 3 hours |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा
अध्ययन के लिए न्यूनतम आयु
28 Weeks
अध्ययन के लिए पात्र लिंग
सभी
- Infants on bCPAP with gestational age < 32+0 weeks
- Postmenstrual age between 28+0 and 36+6 weeks at the time of the study
- Postnatal age greater than 168 hours (7 days) at the time of the study
- On the bubble CPAP device with binasal prongs at the time of the study
- Receiving bubble CPAP levels of 5 to 7 cm H2O with gas flows between 6L/min and 10L/min at the time of the study
- Infants with known major congenital anomalies
- Infants with known congenital heart disorders
- Infants with known neuromuscular disease
- Infants receiving ventilator-derived CPAP at the time of the study
- Infants receiving CPAP via a nasal mask interface at the time of the study
- Infants receiving inotropes, narcotics or sedative agents at the time of the study
- Infants deemed clinically unstable for the study by the attending neonatologist
मैकगिल विश्वविद्यालय239 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिएनॉर्थवेस्टर्न विश्वविद्यालयअध्ययन उत्तरदायी पक्ष
Wissam Shalish, मुख्य अन्वेषक, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
अध्ययन केंद्रीय संपर्क
संपर्क: Wissam Shalish, MD, PhD, 514-412-4400, [email protected]
1 1 देशों में अध्ययन स्थान
Quebec
McGill University Health Center, Montreal, Quebec, H4A 3J1, Canada
Wissam Shalish, MD, PhD, संपर्क, 514-412-4400, [email protected]
Wissam Shalish, MD PhD, मुख्य अन्वेषक
Guilherme Sant'Anna, MD PhD, उप-अन्वेषक
Robert Kearney, MD PhD, उप-अन्वेषक
भर्ती जारी