Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038, China
Location status: Recruiting
Location contact
Jian-Xin Zhou, MD, PhD
CONTACT
Rui-Zhi Zhang,MD
CONTACT
NCT Number: NCT06970990
The aim of this study was to investigate the effects of different oxygen therapy modalities (including nasal cannula oxygen, mask oxygen and high-flow nasal cannula oxygen) on the correlation between Nasal Pressure and Esophageal Pressure by means of a prospective physiological study, to assess the dynamic changes of nasal pressure and esophageal pressure and their underlying mechanisms under different conditions of oxygen therapy, to analyse the effects of oxygen therapy parameters on the relationship between the two, and to explore the feasibility of nasal pressure as a non-invasive monitoring indicator, in order to replaceor supplement esophageal manometry in clinical practice, especially in patients with respiratory distress and instability.Meanwhile, this study will also evaluate the effects of different oxygen therapy modalities on patients' respiratory mechanics and comfort, provide a scientific basis for the clinical selection of individualised oxygen therapy regimens, and ultimately provide new physiological evidence for the management of oxygen therapy in patients with acute respiratory failure in the intensive care unit (ICU) and outside the ICU, promote the development of non-invasive monitoring technology, and improve the clinical prognosis and therapeutic experience of patients.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100038, China
Location status: Recruiting
Jian-Xin Zhou, MD, PhD
CONTACT
Rui-Zhi Zhang,MD
CONTACT
Patients in the intensive care unit (ICU) often require different modalities of oxygen therapy to maintain adequate oxygenation.Common oxygen therapy modalities include nasal cannula oxygen, face mask oxygen and high flow nasal cannula oxygen (HFNC).These modalities of oxygen therapy not only affect the patient's oxygenation status, but may also influence nasal and esophageal pressures by altering the upper airway pressure gradient, which in turn affects respiratory mechanics and patient comfort.
Esophageal pressure fluctuations (ΔPes), as a reflection of mean transpulmonary pressure during unassisted voluntary breathing, provide an important basis for assessing inspiratory effort.However, esophageal manometry still faces many challenges for its bedside implementation in clinical practice, especially in unstable patients with respiratory distress and severely impaired gas exchange.Notably, the COVID-19 pandemic has led to a significant increase in the number of patients with acute respiratory failure, who often require condition-specific oxygen therapy of varying severity and are mostly treated outside the ICU.Given that such patients are at high risk of deterioration, it is particularly important to continuously monitor their inspiratory effort.
nasal pressure is an important physiological indicator for assessing upper airway resistance and airflow dynamics characteristics, whereas esophageal pressure is a key parameter that directly reflects intrathoracic pressure and respiratory effort.Previous studies have shown that there may be a physiological correlation between intranasal pressure and oesophageal pressure, and that this correlation may be influenced by a variety of factors, including airflow velocity, oxygen concentration, and the dynamics of upper airway resistance.Earlier physiological studies by comparing oesophageal pressure fluctuations (ΔPes) with nasal pressure fluctuations (ΔPnose) fluctuations found that when inspiratory effort was increased, there was no significant phase difference between these pressure waveforms.In addition, it was observed that there was a significant correlation between ΔPes and airway pressure fluctuations (ΔPaw) obtained by airway occlusion manoeuvres during inspiratory effort testing.However, although these findings provide important clues for understanding respiratory mechanics, studies on the correlation between nasal pressure and esophageal pressure under different oxygen therapy conditions are still relatively limited, especially lacking data support from prospective physiological studies.Therefore, further systematic studies are needed in the future to investigate in depth the effects of different oxygen therapy parameters (e.g., flow rate, humidity, and temperature, etc.) on the relationship between nasal pressure and esophageal pressure, so as to provide more precise guidance for clinical practice.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Under high-flow oxygen therapy at a flow rate of 50 L/min, record/monitor for 5 minutes
Under high-flow oxygen therapy at a flow rate of 40 L/min, record/monitor for 5 minutes.
Under high-flow oxygen therapy at a flow rate of 30 L/min, record/monitor for 5 minutes.
Under face mask oxygen at a flow rate of 8 L/min, record/monitor for 5 minutes.
Under face mask oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.
Under nasal cannula oxygen at a flow rate of 5 L/min, record/monitor for 5 minutes.
Under nasal cannula oxygen at a flow rate of 3 L/min, record/monitor for 5 minutes.
Time frame: From enrollment to the end of treatment at 4 hours
Tidal swing of nasal pressure (ΔPnose) will be measured
Time frame: From enrollment to the end of treatment at 4 hours
Tidal swing of esophageal pressure (∆Pes) will be measured
Time frame: From enrollment to the end of treatment at 4 hours.
Respiratory rate will be measured at each type of oxygen treatment.
Time frame: From enrollment to the end of treatment at 4 hours
COMFORT scale will be measured
Contact information is provided by the study sponsor or research team.
Jian-Xin Zhou, MD, PhD
CONTACT
Rui-Zhi Zhang,MD
CONTACT
Jian-Xin Zhou
Other
Use of Nasal Pressure to Assess Inspiratory Effort Under Different Oxygen Treatments: a Prospective Physiological Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06968793
Critical Care, Inspiratory Effort
Beijing, Beijing Municipality, China
View Trial DetailsNCT07420946
Airway Clearance, Consensus
Naples, Italy
View Trial DetailsNCT06990295
Critical Care, Focused Ultrasound
Wuhu, Anhui, China
View Trial DetailsNCT07093125
Critical Care, Extubation Failure
Genova, Italy
View Trial Details