Back to resultsSafety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia
Primary Purpose
Hypercapnia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
high flow nasal canula
Sponsored by
About this trial
This is an interventional other trial for Hypercapnia focused on measuring hypercapnia, high flow nasal canula
Eligibility Criteria
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
Sites / Locations
- Mansoura University Hospitals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30)
Arm Description
with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disorders
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of participants in need for ventilation
Secondary outcome was concerned about need to non invasive mechanical ventilation or invasive mechanical ventilation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05948527
Brief Title
Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia
Official Title
Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnia
Keywords
hypercapnia, high flow nasal canula
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30)
Arm Type
Experimental
Arm Description
with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disorders
Intervention Type
Device
Intervention Name(s)
high flow nasal canula
Intervention Description
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%.
Primary Outcome Measure Information:
Title
Arterial Blood Gases changes
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Number of participants in need for ventilation
Description
Secondary outcome was concerned about need to non invasive mechanical ventilation or invasive mechanical ventilation.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
Dakahlia Governorate
ZIP/Postal Code
35511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
study protocol
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Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia
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