Healthy Volunteers Clinical Trial
Official title:
Evaluation of Gas Composition in the Oropharynx During High-flow Oxygen Therapy Through Nasal Cannula in Healthy Volunteers: a Physiological Study
Verified date | December 2023 |
Source | I.M. Sechenov First Moscow State Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Observational, randomized studies and their meta-analyses have shown the high effectiveness of high-flow oxygen therapy through nasal cannulas, reaching 50-60% in acute hypoxemic respiratory failure. Some bench studies showed the advantages of high-flow oxygen therapy compared with standard oxygen therapy, consisting in reducing the anatomical dead space and maintaining a given inspiratory oxygen fraction in the hypopharynx of the mannequin, but the actual state of the gas composition of the hypopharynx was not studied. The study aim is measurement of the inspiratory (FiO2) and expiratory (FeO2) fractions of oxygen, as well as the inspiratory (FiСO2) and expiratory (FeСO2) fractions of carbon dioxide in the hypopharynx of healthy volunteers during high-flow oxygen therapy through nasal cannulas in different physiological conditions.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 1, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Healthy Volunteers - Age over 18 years - Written informed consent. Exclusion Criteria: - Any primary or secondary lung diseases (COPD, bronchial asthma, interstitial lung diseases, metastatic lung disease, lung cancer) - Any chronic diseases that can cause respiratory disorders (chronic heart failure, liver cirrhosis, systemic connective tissue diseases, cancer, neuromuscular diseases etc) - Heart rhythm disturbances - Body mass index more than 30 kg/m2 - Swallowing disorders - History of epileptic syndrome - Recent head surgery or anatomy that precludes the use of nasal cannulas - Pregnancy and lactation period - Inability to cooperate with staff. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Sechenov University Clinic#4 | Moscow |
Lead Sponsor | Collaborator |
---|---|
I.M. Sechenov First Moscow State Medical University |
Russian Federation,
Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17. — View Citation
Grieco DL, Maggiore SM, Roca O, Spinelli E, Patel BK, Thille AW, Barbas CSV, de Acilu MG, Cutuli SL, Bongiovanni F, Amato M, Frat JP, Mauri T, Kress JP, Mancebo J, Antonelli M. Non-invasive ventilatory support and high-flow nasal oxygen as first-line treatment of acute hypoxemic respiratory failure and ARDS. Intensive Care Med. 2021 Aug;47(8):851-866. doi: 10.1007/s00134-021-06459-2. Epub 2021 Jul 7. — View Citation
He Y, Zhuang X, Liu H, Ma W. Comparison of the efficacy and comfort of high-flow nasal cannula with different initial flow settings in patients with acute hypoxemic respiratory failure: a systematic review and network meta-analysis. J Intensive Care. 2023 May 10;11(1):18. doi: 10.1186/s40560-023-00667-2. — View Citation
Ospina-Tascon GA, Calderon-Tapia LE, Garcia AF, Zarama V, Gomez-Alvarez F, Alvarez-Saa T, Pardo-Otalvaro S, Bautista-Rincon DF, Vargas MP, Aldana-Diaz JL, Marulanda A, Gutierrez A, Varon J, Gomez M, Ochoa ME, Escobar E, Umana M, Diez J, Tobon GJ, Albornoz LL, Celemin Florez CA, Ruiz GO, Caceres EL, Reyes LF, Damiani LP, Cavalcanti AB; HiFLo-Covid Investigators. Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19: A Randomized Clinical Trial. JAMA. 2021 Dec 7;326(21):2161-2171. doi: 10.1001/jama.2021.20714. Erratum In: JAMA. 2022 Mar 15;327(11):1093. — View Citation
Perkins GD, Ji C, Connolly BA, Couper K, Lall R, Baillie JK, Bradley JM, Dark P, Dave C, De Soyza A, Dennis AV, Devrell A, Fairbairn S, Ghani H, Gorman EA, Green CA, Hart N, Hee SW, Kimbley Z, Madathil S, McGowan N, Messer B, Naisbitt J, Norman C, Parekh D, Parkin EM, Patel J, Regan SE, Ross C, Rostron AJ, Saim M, Simonds AK, Skilton E, Stallard N, Steiner M, Vancheeswaran R, Yeung J, McAuley DF; RECOVERY-RS Collaborators. Effect of Noninvasive Respiratory Strategies on Intubation or Mortality Among Patients With Acute Hypoxemic Respiratory Failure and COVID-19: The RECOVERY-RS Randomized Clinical Trial. JAMA. 2022 Feb 8;327(6):546-558. doi: 10.1001/jama.2022.0028. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inspiratory oxygen fraction (FiO2) in the hypopharynx | Inspiratory oxygen fraction (FiO2) in the hypopharynx during different physiological conditions | 5 minutes | |
Primary | Expiratory oxygen fraction (FeO2) in the hypopharynx | Expiratory oxygen fraction (FeO2) in the hypopharynx during different physiological conditions | 5 minutes | |
Primary | Inspiratory fraction of carbon dioxide (FiCO2) in the hypopharynx | Inspiratory fraction of carbon dioxide (FiCO2) in the hypopharynx during different physiological conditions | 5 minutes | |
Primary | Expiratory fraction of carbon dioxide (FeCO2) in the hypopharynx | Expiratory fraction of carbon dioxide (FeCO2) in the hypopharynx during different physiological conditions | 5 minutes | |
Secondary | Respiratory rate (RR) | Respiratory rate (RR) during different physiological conditions | 5 minutes | |
Secondary | Tidal volume (VT) | Tidal volume (VT) during different physiological conditions | 5 minutes | |
Secondary | Peripheral oxygen saturation (SpO2) | Peripheral oxygen saturation (SpO2) during different physiological conditions | 5 minutes | |
Secondary | Modified ventilatory ratio (mVR) | Modified ventilatory ratio (mVR) during different physiological conditions. mVR = [RR * tidal volume* (PetCO2 (mmHg) - 4 mmHg)] / [predicted body weight (kg) * 100 * 37,5 mmHg] | 5 minutes | |
Secondary | The ratio of oxygen saturation by pulse oximetry/inspiratory oxygen fraction to respiratory rate (ROX-index) | ROX-index (SpO2/FiO2/RR) during different physiological conditions | 5 minutes | |
Secondary | Comfort | Visual-analog scale (VAS) for comfort evaluation (from 1 to 10, 1-full comfort, 10-full comfort) | 5 minutes |
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