Gas Composition in the Oropharynx During High-flow Oxygen Therapy Through Nasal Cannula in Healthy Volunteers

NCT06189716 | Completed

• 1 other identifier: HFNC-OXIMETRY
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

healthy volunteers; HFNC; high flow oxygen; oximetry; capnometry; pharyngeal

Outcome Measures

Primary Outcomes (4)

• Inspiratory oxygen fraction (FiO2) in the hypopharynx

  Inspiratory oxygen fraction (FiO2) in the hypopharynx during different physiological conditions

  5 minutes

• Expiratory oxygen fraction (FeO2) in the hypopharynx

  Expiratory oxygen fraction (FeO2) in the hypopharynx during different physiological conditions

  5 minutes

• Inspiratory fraction of carbon dioxide (FiCO2) in the hypopharynx

  Inspiratory fraction of carbon dioxide (FiCO2) in the hypopharynx during different physiological conditions

  5 minutes

• 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 Outcomes (6)

• Respiratory rate (RR)

  5 minutes

• Tidal volume (VT)

  5 minutes

• Peripheral oxygen saturation (SpO2)

  5 minutes

• Modified ventilatory ratio (mVR)

  5 minutes

• The ratio of oxygen saturation by pulse oximetry/inspiratory oxygen fraction to respiratory rate (ROX-index)

  5 minutes

Study Arms (1)

Experimental

EXPERIMENTAL

High flow oxygen through nasal cannula, oxygen and carbon dioxide measurement in the hypopharynx

Device: High flow oxygen through nasal cannula

Interventions

High flow oxygen through nasal cannula DEVICE

High flow oxygen through nasal cannula and measurement of oxygen and carbon dioxide fraction in the hypopharynx of healthy volunteers in different physiological conditions.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Volunteers
• Age over 18 years
• Written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Sechenov University Clinic#4

Moscow, Moscow, Russia

Location

Related Publications (6)

• 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.

  PMID: 25981908 BACKGROUND

• 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.

  PMID: 34232336 BACKGROUND

• 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.

  PMID: 37165464 BACKGROUND

• 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.

  PMID: 34874419 BACKGROUND

• 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.

  PMID: 35072713 BACKGROUND

• Yaroshetskiy AI, Krasnoshchekova AP, Tkachenko FD, Rubashchenko AV, Zubarev DD, Konanykhin VD, Savelenok MI, Nosenko MM, Merzhoeva ZM, Avdeev SN. Gas composition and pressure in the hypopharynx during high-flow oxygen therapy through a nasal cannula in healthy volunteers with different breathing patterns. BMC Anesthesiol. 2025 Aug 23;25(1):416. doi: 10.1186/s12871-025-03267-9.

  PMID: 40849448 DERIVED

Study Officials

• Andrey I Yaroshetskiy, MD, PhD, ScD

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Measurement of the inspiratory (FiO2) and expiratory (FeO2) fractions of oxygen (FiСO2 and FeСO2, respectively), as well as the inspiratory and expiratory fractions of carbon dioxide (FiСO2 and FeСO2, respectively) in the hypopharynx of healthy volunteers during high-flow oxygen therapy through nasal cannulas in different physiological conditions

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 3, 2024
• Study Start: January 9, 2024
• Primary Completion: April 30, 2024
• Study Completion: June 10, 2024
• Last Updated: October 8, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)