Clinical trial NCT03738345: The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients
Official title: The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Keywords: High flow nasal cannula
Hypoxemia
Flow setting
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: High flow nasal cannula (HFNC) delivers oxygen at a flow which exceeds the patient's inspiratory flow demand in order to improve oxygenation. Numerous randomized control trials and meta-analyses have shown that HFNC improves oxygenation and helps avoid intubation in hypoxemic patients, as well as reduce work of breathing, improve ventilation, and decrease hypercapnia in COPD patients. Flow settings play a critical role when using HFNC, as increased flow can reduce inspiratory effort, improve ventilation, and dynamic lung compliance. However, flow rates used in many studies vary widely. The clinical effects of different HFNC flow setting, specifically to match or over than a patients' own inspiratory flow, is still unknown.

Detailed description: High flow nasal cannula (HFNC) delivers oxygen at a flow which exceeds the patient's inspiratory flow demand in order to improve oxygenation. Numerous randomized control trials and meta-analyses have shown that HFNC improves oxygenation and helps avoid intubation in hypoxemic patients, as well as reduce work of breathing, improve ventilation, and decrease hypercapnia in COPD patients. Flow settings play a critical role when using HFNC, as increased flow can reduce inspiratory effort, improve ventilation, and dynamic lung compliance. However, flow rates used in many studies vary widely, from 20-40 LPM in COPD patients and 30-60 LPM in hypoxemic patients. The clinical effects of different HFNC flow setting, specifically to match or over than a patients' own inspiratory flow, is still unknown.

Eligibility criteria: Inclusion Criteria:

Adult patients (Age \> 18yrs and \< 90yrs) who need nasal cannula oxygen flow ≥ 5 L/min to maintain SpO2 at 90-97%.

Exclusion Criteria (Common): - Unable to use resuscitation mask, such as facial trauma, claustrophobia

* Inability to verbally communicate;
* Pregnant
* Inability to breathe via nose, such as nasosinusitis, stuffy nose or nasal obstruction, etc.
* Ordered SpO2 goal is above 97%
* FIO2 needs ≤ 0.4
* Using inhaled pulmonary vasodilator via HFNC

Primary outcomes:
measure: SpO2/FIO2 increment for hypoxemic patients
timeFrame: 30 minutes
measure: RR change for hypoxemic patients
timeFrame: 30 minutes
Secondary outcomes:
measure: comfort scores
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University
name: Jie Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ni YN, Luo J, Yu H, Liu D, Ni Z, Cheng J, Liang BM, Liang ZA. Can High-flow Nasal Cannula Reduce the Rate of Endotracheal Intubation in Adult Patients With Acute Respiratory Failure Compared With Conventional Oxygen Therapy and Noninvasive Positive Pressure Ventilation?: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):764-775. doi: 10.1016/j.chest.2017.01.004. Epub 2017 Jan 13.
citation: Pisani L, Fasano L, Corcione N, Comellini V, Musti MA, Brandao M, Bottone D, Calderini E, Navalesi P, Nava S. Change in pulmonary mechanics and the effect on breathing pattern of high flow oxygen therapy in stable hypercapnic COPD. Thorax. 2017 Apr;72(4):373-375. doi: 10.1136/thoraxjnl-2016-209673. Epub 2017 Jan 19.
citation: Mauri T, Alban L, Turrini C, Cambiaghi B, Carlesso E, Taccone P, Bottino N, Lissoni A, Spadaro S, Volta CA, Gattinoni L, Pesenti A, Grasselli G. Optimum support by high-flow nasal cannula in acute hypoxemic respiratory failure: effects of increasing flow rates. Intensive Care Med. 2017 Oct;43(10):1453-1463. doi: 10.1007/s00134-017-4890-1. Epub 2017 Jul 31.
citation: Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
citation: Delorme M, Bouchard PA, Simon M, Simard S, Lellouche F. Effects of High-Flow Nasal Cannula on the Work of Breathing in Patients Recovering From Acute Respiratory Failure. Crit Care Med. 2017 Dec;45(12):1981-1988. doi: 10.1097/CCM.0000000000002693.
citation: Li J, Scott JB, Fink JB, Reed B, Roca O, Dhand R. Optimizing high-flow nasal cannula flow settings in adult hypoxemic patients based on peak inspiratory flow during tidal breathing. Ann Intensive Care. 2021 Nov 27;11(1):164. doi: 10.1186/s13613-021-00949-8.