High Flow Nasal Cannula Versus Non-invasive Ventilation in Prevention of Escalation to Invasive Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure

NCT03788304 | Unknown

• 1 other identifier: High flow nasal cannula
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Oxygen therapy is first-line treatment in the management of acute respiratory failure (ARF). Different oxygen devices have become available over recent decades, such as low-flow systems (nasal cannula, simple facemask, non-rebreathing reservoir mask) and high-flow systems (Venturi mask) . Since the 90's, non-invasive ventilation (NIV) has been largely used with strong level of evidence in cardiogenic pulmonary edema and chronic obstructive pulmonary disease (COPD) exacerbation. NIV improves gas exchange and reduces inspiratory effort through positive pressure. However, good tolerance to NIV is sometimes difficult to achieve due to frequent leaks around the mask, possibly leading to patient-ventilator asynchrony and even to intubation . High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters\\ min of heated and fully humidified gas with a FIO2 ranging between 21% and 100% . It is a new method of respiratory support in adults that has been used in neonatal ARF for some years. The reason this study is necessary is because, even though NIV has been demonstrated to prevent endotracheal intubation (and its associated complications) in a broad range of ARF patients, HFNC has been proposed to have the same effect as NIV while being easier tolerated, more physiological , allowing patients to continue to talk, eat and drink through mouth while on HFNC

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Endotracheal intubation rate.

  needs escalation to invasive mechanical ventilation

  one week

Secondary Outcomes (5)

• In hospital mortality.

  one week

• length of hospital stay

  one week

• duration of ICU stay

  one week

• duration of intervention

  one week

• development of complications

  one week

Study Arms (2)

Non invasive ventilation

ACTIVE COMPARATOR

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%

Device: non-invasive ventilation

High flow nasal cannula

EXPERIMENTAL

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%

Device: high flow nasal cannula

Interventions

non-invasive ventilation DEVICE

conventional NIV

Non invasive ventilation

high flow nasal cannula DEVICE

HFNC ventilation

High flow nasal cannula

Eligibility Criteria

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

You may qualify if:

• Participants admitted to the RICU with acute hypoxemic respiratory failure requiring NIV support 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

You may not qualify if:

• Patients who have any of the following:
• I. Indication for emergency endotracheal intubation. II. HR \<50 beat\\minute with decreased level of consciousness III. Persistent hemodynamic instability with
• Systolic blood pressure \<90 mmHg after infusing a bolus of crystalloid solution at a dose of 30 ml / kg
• life-threatening arrhythmia. IV. Undrained pneumothorax or Pneumothorax with persistent air leak. V. Extensive facial trauma or burn VI. Refusal to participate. VII. Usual long-term treatment with NIV for chronic disease VIII. Altered mental status with decreased consciousness and/or evidence of inability to understand .
• IX. Tracheotomy or other upper airway disorders X. Active upper gastrointestinal bleeding

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University hospital

Asyut, assiut University 71515, Egypt

RECRUITING

Related Publications (1)

• 1-Renda, T., Corrado, A., Iskandar, G., et al. High-flow nasal oxygen therapy in intensive care and anaesthesia . British journal of anaesthesia 2018 , 120(1), 18-27 2-Kallstrom TJ. AARC clinical practice guideline: oxygen therapy for adults in the acute care facility: 2002 revision and update. Respir Care 2002; 47: 717-20. 3-O'Driscoll BR, Howard LS, Davison AG, on behalf of the British Thoracic Society. BTS guideline for emergency oxygen use in adult patients. Thorax 2008; 63: 1-68. 4-Sim MA, Dean P, Kinsella J, et al. Performance of oxygen delivery devices when the breathing pattern of respiratory failure is simulated. Anaesthesia 2008; 63: 938-40 5-Nishimura, M. High-flow nasal cannula oxygen therapy in adults: physiological benefits, indication, clinical benefits, and adverse effects. Respiratory Care 2016, 61(4), 529-541.

  BACKGROUND

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

• Mohamed F Adam, lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

• Manal A El-Khawaga, lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Entsar H mohamed, MD

CONTACT

+201019968106; dr.entsar_hsanen@yahoo.com

Gamal M Rabie, professor

CONTACT

+201155213224; Gamalagmy135@gmail.com

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: principle 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: December 20, 2018
• First Posted: December 27, 2018
• Study Start: May 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: December 1, 2020
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

EG (1)