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

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).

Study Overview

• Status: Completed
• Conditions: Hypercapnia
• Intervention / Treatment: Device: high flow nasal canula

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia Governorate
    • Mansoura, Dakahlia Governorate, Egypt, 35511
      • Mansoura university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30); with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disorders	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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants in need for ventilation	Secondary outcome was concerned about need to non invasive mechanical ventilation or invasive mechanical ventilation.	7 days

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: hypercapnia; high flow nasal canula
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypercapnia
• Other Study ID Numbers: R.22.12.1978.R1.R2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: study protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No