High Flow Nasal Cannula Versus Non-Invasive (NIV)in Both Hypoxemic and Hypercapnic Respiratory Failure.

NCT05499039 | Unknown

• 1 other identifier: HFNC VS NIV
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21 % to 1 00% FiO2 delivery and generates up to 60 L/min flow rates The gas is heated and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the patient through a large diameter nasal cannula Theoretically, HFNC offers significant advantages in oxygenation and ventilation over COT. Constant high flow oxygen delivery provides steady FiO2 and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation The heated humidification facilitates secretion clearance, decreases bronchospasm, and maintains mucosal integrity. This study aims to evaluate the effectiveness of HFNC compared to NIMV in management of Acute hypoxemic and acute hypercapneic respiratory failure

Conditions

Acute Hypoxemic Respiratory Failure; Acute Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (5)

• Evaluation of HFNC and NIV in correction of Acidosis .

  Evaluation of the effectiveness of HFNC VS NIV in correction of Acidosis through measurement of PH via arterial blood gases test (ABG). Evaluation of the effectiveness of HFNC in correction of Acidosis through measurement of PH via arterial blood gases test (ABG).

  Baseline

• Evaluation of HFNC and NIV in correction of Hypercapnia.

  Evaluation of the effectiveness of HFNC VS NIV in correction of Hypercapnia through measurement of PCO2 by mmHg via arterial blood gases test (ABG)

  Baseline

• Evaluation of HFNC and NIV in management of Acute hypoxemic respiratory failure.

  Evaluation of the effectiveness of HFNC VS NIV in management of Acute hypoxemic respiratory failure through measurement of PO2 via arterial blood gases test (ABG)

  Baseline

• Evaluation of HFNC and NIV in correction of Hypoxemia.

  Evaluation of the effectiveness of HFNC VS NIV in correction of Hypoxemia through measurement of O2 saturation by percentage % via pulse oximeter.

  Baseline

• Endotracheal intubation rate.

  needs escalation to invasive mechanical ventilation

  Baseline

Secondary Outcomes (5)

• In hospital mortality.

  one month

• duration of intervention

  one month

• hospital coast

  one month

• duration of ICU stay .

  one month

• development of complications

  one month

Study Arms (4)

Group A1 (NIVMV on hypoxemic)

ACTIVE COMPARATOR

Use of NIV on acute hypoxemic respiratory failure patients

Device: Non-Invasive Mechanical Ventilation (NIV)

Group A2 (HFNC on hypoxemic)

EXPERIMENTAL

Use of HFNC on acute hypoxemic respiratory failure patients

Device: High flow nasal cannula (HFNC)

Group B1 (NIVMV on hypercapneic)

ACTIVE COMPARATOR

Use of NIV on acute hypercapneic respiratory failure patients

Device: Non-Invasive Mechanical Ventilation (NIV)

Group B2 (HFNC on hypercapneic)

EXPERIMENTAL

Use of HFNC on acute hypercapneic respiratory failure patients

Device: High flow nasal cannula (HFNC)

Interventions

High flow nasal cannula (HFNC) DEVICE

High flow nasal cannula consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers a modified gas flow up to 60 l/ min . will be set with: - Temperature at 37°C or 34°C Flow rate 30: 50 L/min. FiO2 will be adjusted to achieve a SpO2 at least 95%

Also known as: High velocity nasal insufflation (vapotherm)

Group A2 (HFNC on hypoxemic); Group B2 (HFNC on hypercapneic)

Non-Invasive Mechanical Ventilation (NIV) DEVICE

Respiratory assistance is provided by a NIV either Puritan Bennet 840 , Engström Carestation or Hamilton-G5 , will be used for conventional non-invasive ventilation via an oronasal mask. Settings will be adjusted based on the clinical assessment of the respiratory therapist . Initial setting includes: - Positive End Expiratory Pressure (PEEP): 5 cmH2O. Pressure support (PS): 12-20 cmH2O. FiO2 will be adjusted to achieve a SpO2 at least 95% Intervention: Device: non-invasive ventilation

Group A1 (NIVMV on hypoxemic); Group B1 (NIVMV on hypercapneic)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18
• Acute hypoxemic respiratory failure. (Participants admitted with acute hypoxemic respiratory with the following criteria:
• RR\> 25 breath/minute Use of accessory muscles of respiration, paradoxical breathing, thoracoabdominal asynchrony.
• Hypoxemia evidenced by PaO2 / FiO2 ratio \<300)
• Acute hypercapnic respiratory failure ((Participants admitted with acute hypercapneic respiratory with the following criteria:
• pO2 less than 60 mm Hg (hypoxemia). pCO2 greater than 50 mm Hg (hypercapnia) with pH less than 7.35. Signs and symptoms of acute respiratory distress)

You may not qualify if:

• Patients with preprocedural or post-procedural settings (ex: surgery, bronchoscope) post- extubation,
• Patients with cancer or transplant patients,
• Patients less than 18 years old
• Patients with Heart failure patients
• Patients with renal failure patients
• Patients with hemodynamic instability
• Patients with central causes of hypercapnic respiratory failure
• Patients with disturbed conscious level
• Patients who refuse to participate in the study
• Indication for emergency endotracheal intubation
• Tracheotomy or other upper airway disorders
• Active upper gastrointestinal bleeding

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Zein Al-abdeen Ah Sayed, professor

  Assiut University

  STUDY DIRECTOR

• Taghred SA Meshref, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelrahman Mo Alham, Demonstrator

CONTACT

01014546379; abdoverno@gmail.com

Peter At Rizk

CONTACT

01553529181

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the participant , care provider , the investigator nor the outcome assessor will select patients in both groups , see results of other patients till the end of the study or informed by literature opinion in this intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: patients with will be randomly enrolled to either non invasive group or HFNC group and improvement and patient satisfaction will be assessed

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: August 12, 2022
• Study Start: October 10, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 20, 2024
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)