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

Hypoxia Clinical Trial

Official title:

Comparison of Regional Ventilation Pattern During High Flow Nasal Cannula Between Conventional Low Flow System Nasal Cannula in Patients With Mild to Moderate Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943863
• Other study ID #: OMNI
• Status: Completed
• Phase: N/A
• First received: October 21, 2016
• Last updated: October 23, 2016
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anoxia
• High Flow Nasal Cannula
• Hypoxia
• Oxygen Therapy
• Ventilation

Intervention

Device:
• HFNC followed by conventional nasal cannula

• Conventional nasal cannula followed by HFNC

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Ministry of Trade, Industry and Energy of Korea

References & Publications (3)

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. — View Citation

Riera J, Pérez P, Cortés 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. — View Citation

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):253-61. doi: 10.1378/chest.14-2871. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal variation	Tidal variation using electric impedance tomography	Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)	No
Secondary	Oxygen saturation	Oxygen saturation at using pulse oxymeter	Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)	No
Secondary	Respiration Rate		Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)	No
Secondary	Subjective comfort	Subjective comfort using questionnaire	Twenty minutes after each oxygen therapy. (At the end of each oxygen therapy)	No