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

NCT02943863 | Completed

• 1 other identifier: OMNI
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypoxia; Oxygen Therapy; High Flow Nasal Cannula; Ventilation

Outcome Measures

Primary Outcomes (1)

• Tidal variation

  Tidal variation using electric impedance tomography

  Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)

Secondary Outcomes (3)

• Oxygen saturation

  Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)

• Respiration Rate

  Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)

• Subjective comfort

  Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)

Study Arms (2)

HFNC first

ACTIVE COMPARATOR

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.

Device: HFNC followed by conventional nasal cannula

LFS first

ACTIVE COMPARATOR

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.

Device: Conventional nasal cannula followed by HFNC

Interventions

HFNC followed by conventional nasal cannula DEVICE

HFNC first

Conventional nasal cannula followed by HFNC DEVICE

LFS first

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Ministry of Trade, Industry & Energy, Republic of Korea: collaborator

Related Publications (4)

• 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.

  PMID: 25742321 BACKGROUND

• 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.

  PMID: 23050520 BACKGROUND

• 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.

  PMID: 25843526 BACKGROUND

• 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.

  PMID: 31723854 DERIVED

MeSH Terms

Conditions

Hypoxia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Chae-Man Lim, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pulmonary and Critical Care Medicine, College of Medicine, University of Ulsan. Chief Director of Intensive Care Units, Asan Medical Center

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 25, 2016
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 25, 2016

Record last verified: 2016-10