The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients

Hypoxemia Clinical Trial

Official title:

The Effects of Flow Settings During High Flow Nasal Cannula for Adult Hypoxemia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738345
• Other study ID #: HFNC-Flow-003
• Status: Completed
• Phase: N/A
• Start date: December 26, 2018
• Est. completion date: March 30, 2021

Study information

• Verified date: April 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

Other:
• HFNC flow
HFNC flow will be titrated based on the hospital's policy or protocol for hypoxemic patients and research protocol for healthy volunteers

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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 — View 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. — View 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 Pressu — View 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2/FIO2 increment for hypoxemic patients	SpO2/FIO2 at the optimal/maximum /tolerable/ HFNC flow setting compared to the SpO2/FIO2 at HFNC flow matching patient's inspiratory flow or 30 L/min for hypoxemic patients	30 minutes
Primary	RR change for hypoxemic patients	Respiratory rates at the optimal/maximum /tolerable/ HFNC flow setting compared to the SpO2/FIO2 at HFNC flow matching patient's inspiratory flow or 30 L/min for hypoxemic patients	30 minutes
Secondary	comfort scores	comfort will be self-evaluation using a visual analog scale with measured score of 0 is the worst and 10 is the best	30 minutes