NCT05948527

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
Last Updated

July 17, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 24, 2023

Last Update Submit

July 13, 2023

Conditions

Keywords

hypercapniahigh flow nasal canula

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of participants in need for ventilation

    7 days

Study Arms (1)

with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30)

EXPERIMENTAL

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

Interventions

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%.

with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with mild Hypercapnia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 17, 2023

Study Start

January 1, 2023

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 17, 2023

Record last verified: 2023-06

Locations