Efficiency of HFNC Vs NIV in Patient With Acute Type 2 RF

NCT05698641 | Completed

• 1 other identifier: FMBSUREC/01092020/Ali
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In acute hypoxic respiratory failure, high-flow nasal cannula (HFNC) oxygen treatment is gaining popularity. However, there is just a small body of research to back up the use of HFNC in acute respiratory failure (ARF) with hypercapnia. Aim of study: To evaluate the effectiveness of high-flow nasal cannula (HFNC) in reducing the rate of endotracheal intubation and PCO2 level in adult patients with Acute moderate type II respiratory failure in comparison to noninvasive positive pressure ventilation (NIPPV). Methods : A randomized control trial that was conducted on patients with acute moderate hypercapnic respiratory failure ARF (arterial blood gases pH 7.25-7.35, PaCO2\>45 mmHg) who were admitted to respiratory and medical critical care units from September 2020 through February 2022 and received HFNC or NIV .The endpoint was treatment failure, which was indicated by either invasive ventilation or mortality .

Conditions

Type 2 Respiratory Failure

Keywords

type2 RF; HFNC; NIV

Outcome Measures

Primary Outcomes (1)

• failure of treatment modality

  failure of improvement of PH

  1 hour

Secondary Outcomes (2)

• mortality

  28 day

• ICU stay

  28 day

Study Arms (2)

HFNC

Patients treated with HFNC

NIV

Patients treated with NIV

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients of both sex who were admitted to ICU with acute moderate hypercapnic respiratory failure. Included patients were divided into two groups: * Group A: 50 patients with acute moderate hypercapnic respiratory failure who were treated with HFNC as ventilatory support . * Group B: 50 patients with acute moderate hypercapnic respiratory failure who were treated with NIV as ventilatory support .

You may not qualify if:

• Patients aged \<18 years
• Patients with altered consciousness defined by a Glasgow coma score of \>12 points.
• Hemodynamic instability defined by systolic arterial blood pressure 90 mmHg, mean arterial blood pressure 65 mm Hg, on vasopressor, confusion , chest pain or loss of consciousness )
• PH\>7.25
• Patients who need immediate endotracheal intubation.
• Contraindication to NIV (oral and facial trauma, excessive phlegm with poor expectoration ability, vomiting and Epistaxis)
• Post cardiac arrest patients.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Faculty of medicine

Banī Suwayf, Beni Suweif Governorate, Egypt

Location

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 26, 2023
• Study Start: September 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

EG (1)