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

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05948527
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hypercapnia	Device: high flow nasal canula	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia
• Actual Study Start Date: Jan 1, 2023
• Actual Primary Completion Date: Jul 1, 2023
• Actual Study Completion Date: Jul 1, 2023

Arms and Interventions

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%.

Outcome Measures

Primary Outcome Measures

1. Arterial Blood Gases changes [48 hours]

   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

1. Number of participants in need for ventilation [7 days]

   Secondary outcome was concerned about need to non invasive mechanical ventilation or invasive mechanical ventilation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospitals	Mansoura	Dakahlia Governorate	Egypt	35511

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT05948527
• Other Study ID Numbers: R.22.12.1978.R1.R2
• First Posted: Jul 17, 2023
• Last Update Posted: Jul 17, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mansoura University: hypercapnia; high flow nasal canula
• Additional relevant MeSH terms: Hypercapnia

Study Results

No Results Posted as of Jul 17, 2023