Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia

NCT ID: NCT02943863

Last Updated: 2016-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-02-28

Brief Summary

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High-flow nasal cannula (HFNC) that uses heated and humidified oxygen was recently introduced for bedside care. It has been shown to be associated with reduced risks of tracheal intubation rates and mortality in adult hypoxic patients.

The mechanisms of the effects of HFNC are thought to be related to the favorable effects of the heated and humidified gas, the high-flow rate used to minimize the entrainment of room air, and an increase in the ventilation efficiency, including the elimination of nasopharyngeal dead space, positive end-expiratory pressure (PEEP) effects, and improvements in paradoxical abdominal movement. Regarding the effects on lung volume, global ventilation in the lungs increases during HFNC, which is thought to attribute to PEEP effects. However, how regional ventilation is affected during HFNC in comparison with conventional NC remains unknown.

Because PEEP in mechanically ventilated patients improves the regional homogeneity of ventilation, investigators postulated that HFNC via PEEP effects would result in more homogeneous regional distributions in the ventilation changes. Investigators therefore assessed global and regional ventilation in patients with hypoxia receiving care via HFNC using electric impedance tomography and compared these results with conventional nasal cannula.

Detailed Description

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Conditions

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Hypoxia Oxygen Therapy High Flow Nasal Cannula Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HFNC first

Patients in "HFNC first" receive oxygen therapy using HFNC in ahead of conventional nasal cannula oxygen therapy. After 20 minutes of HFNC therapy, patients receive conventional nasal cannula oxygen therapy.

Group Type ACTIVE_COMPARATOR

HFNC followed by conventional nasal cannula

Intervention Type DEVICE

LFS first

Patients in "LFS first" receive oxygen therapy using conventional nasal cannula in ahead of HFNC therapy. After 20 minutes of conventional nasal cannula oxygen therapy, patients receive HFNC oxygen therapy.

Group Type ACTIVE_COMPARATOR

Conventional nasal cannula followed by HFNC

Intervention Type DEVICE

Interventions

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HFNC followed by conventional nasal cannula

Intervention Type DEVICE

Conventional nasal cannula followed by HFNC

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \>20 years
* Subjective dyspnea in room air
* SaO2\< 90% in room air
* Oxygen requirement for nasal cannula \< 6 L/m

Exclusion Criteria

* Unstable vital signs

* SBP \<90 mmHg
* DBP \< 60 mmHg
* Heart rate \> 120 bpm
* Respiratory rate \> 30 bpm
* Persistent dyspnea under oxygen therapy using NC
* Severe hypoxia

* PaO2/FiO2\< 200 mmHg
* Unable to cooperate

* Delirium
* Reduced cognitive function
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Trade, Industry & Energy, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Chae-Man Lim

Professor of Pulmonary and Critical Care Medicine, College of Medicine, University of Ulsan. Chief Director of Intensive Care Units, Asan Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chae-Man Lim, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary and Critical Care Medicine, Asan Medical Center, College of Medicine, University of Ulsan

References

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Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.

Reference Type BACKGROUND
PMID: 25742321 (View on PubMed)

Riera J, Perez P, Cortes J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02086.

Reference Type BACKGROUND
PMID: 23050520 (View on PubMed)

Hsu CF, Cheng JS, Lin WC, Ko YF, Cheng KS, Lin SH, Chen CW. Electrical impedance tomography monitoring in acute respiratory distress syndrome patients with mechanical ventilation during prolonged positive end-expiratory pressure adjustments. J Formos Med Assoc. 2016 Mar;115(3):195-202. doi: 10.1016/j.jfma.2015.03.001. Epub 2015 Apr 3.

Reference Type BACKGROUND
PMID: 25843526 (View on PubMed)

Lee DH, Kim EY, Seo GJ, Suh HJ, Huh JW, Hong SB, Koh Y, Lim CM. Global and Regional Ventilation during High Flow Nasal Cannula in Patients with Hypoxia. Acute Crit Care. 2018 Feb;33(1):7-15. doi: 10.4266/acc.2017.00507. Epub 2018 Jan 22.

Reference Type DERIVED
PMID: 31723854 (View on PubMed)

Other Identifiers

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OMNI

Identifier Type: -

Identifier Source: org_study_id