Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia

Hypercapnia Clinical Trial

Official title:

Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05948527
• Other study ID #: R.22.12.1978.R1.R2
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: June 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate safety and efficacy of application ( high flow nasal canula) in cases with mild hypercapnia, included 30 patients who were hospitalized in Mansoura University chest department with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disease categories (Chronic obstructive pulmonary disease acute exacerbation, pneumonia, Interstitial lung diseases, etc).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients with mild Hypercapnia

Exclusion Criteria:

• Excluded cases had age less than 18 years or pediatric group .

• patients with their mental state altered, confused, comatose, severe agitation or non cooperative

• Cases with moderate or severe Hypercapnia

• cases in need for immediate invasive mechanical ventilation

• cases with respiratory rate more than 35 breath per minute.

• cases with Respiratory exhaustion , fatigue , excess use of respiratory accessory muscles

• Shock , hemodynamic instability, post arrest cases,

• cases with facial trauma or severe nasal deformity,

• Patients with sleep breathing disorders or upper airway obstruction

• patients with history of home ventilation prior admission

Related Conditions & MeSH terms

• Hypercapnia

Intervention

Device:
• high flow nasal canula
administration of high flow nasal canula at initial flow 35 liters per minute and Fio2 (fraction of inspired oxygen of 50%) with titration to reach oxygen saturation of 88-92%.

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansoura	Dakahlia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial Blood Gases changes	The primary outcome was concerned about changes in Arterial Blood Gases in first 24 h after admission and the same changes 48 h after admission.	48 hours
Secondary	Number of participants in need for ventilation	Secondary outcome was concerned about need to non invasive mechanical ventilation or invasive mechanical ventilation.	7 days