High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing The Rate of Reintubation

High Flow Nasal Cannula Versus Non Invasive Positive Pressure Ventilation in Reducing Reintubation in Mechanically Ventilated Patient

This is study aim to compare between high flow nasal canula (HFNC) and non invasive positive pressure ventilation (NIPPV) in reducing the rate of reintubation in mechanically ventilated patient with successful weaning

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure; Re-intubation Rate
• Intervention / Treatment: Device: high flow nasal cannula; Device: non invasive positive pressure ventilation

Detailed Description

• High-flow nasal cannula (HFNC) oxygen therapy comprises an air/oxygen blender, an active humidifier, a single heated circuit, and a nasal cannula. It delivers adequately heated and humidified medical gas at up to 60 L/min of flow and is considered to have a number of physiological effects: reduction of anatomical dead space, positive end expiratory pressure ( PEEP ) effect, constant fraction of inspired oxygen, and good humidification
• Noninvasive positive-pressure ventilation is a safe and effective means of improving gas exchange in patients with many types of acute respiratory failure . for example, adding noninvasive ventilation to standard therapy decreased the need for endotracheal intubation...For patients assigned to noninvasive ventilation, the ventilator was connected with conventional tubing to a clear, full-face mask with an inflatable soft-cushion seal and a disposable foam spacer to reduce dead space .After the mask had been secured, pressure support was increased to achieve an exhaled tidal volume of 8 to 10 ml per kilogram, a respiratory rate of fewer than 25 breaths per minute, the disappearance of accessory muscle activity (as evaluated by palpation of the sternocleidomastoid muscle), and patient comfort
• The effects of high-flow nasal cannula (HFNC) on adult patients with acute respiratory failure (ARF) are controversial. The investigators aimed to further determine the effectiveness of HFNC in reducing the rate of endotracheal intubation in adult patients with ARF by comparison to noninvasive positive pressure ventilation (NIPPV)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed osman shehata abdelkareem, resident doctor; Phone Number: +201123368743; Email: abkmod@gmail.com
• Study Contact Backup: Name: Maha Kamel Ghanem, professor; Phone Number: +201227694434; Email: mahaghanem@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patient suffer from acute respiratory failure and intubated for mechanical ventilation and then extubated for weaning
• Age >18 years old

Exclusion Criteria:

• In patients less than 18 years old
• Any contradiction in using HFNC as trauma or surgery or obstruction of nasopharynx
• Any contradiction in using NIPPV as facial trauma ..surgery ..deformity..or upper airway obstruction or upper gastrointestinal bleeding or high risk of aspiration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: high flow nasal cannula group; patients put on high flow nasal cannula after extubation	Device: high flow nasal cannula; device are used for weaning patients after mechanical ventilation extubation
Active Comparator: non invasive positive pressure ventilation group; patients put on non invasive positive pressure ventilation group after extubation	Device: non invasive positive pressure ventilation; device are used for weaning patients after mechanical ventilation extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the need for re-intubation and weaning success which will be measured by arterial blood gas ( ABG )	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of using of HFNC or NIPPV		up to 30 days
Length of hospital stay measured by days		up to 30 days
In - hospital mortality measured by number of died cases		up to 30 days
Adverse events	Adverse events (occurrence of nosocomial pneumonia based on clinical and laboratory and radiological finding, need for MV measured by re-intubation rate)	up to 30 days
Incidence of any possible complications associated with the use of HFNC and NIPPV		up to 30 days

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
• Ni YN, Luo J, Yu H, Liu D, Ni Z, Cheng J, Liang BM, Liang ZA. Can High-flow Nasal Cannula Reduce the Rate of Endotracheal Intubation in Adult Patients With Acute Respiratory Failure Compared With Conventional Oxygen Therapy and Noninvasive Positive Pressure Ventilation?: A Systematic Review and Meta-analysis. Chest. 2017 Apr;151(4):764-775. doi: 10.1016/j.chest.2017.01.004. Epub 2017 Jan 13.
• Gomez-Merino E, Sancho J, Marin J, Servera E, Blasco ML, Belda FJ, Castro C, Bach JR. Mechanical insufflation-exsufflation: pressure, volume, and flow relationships and the adequacy of the manufacturer's guidelines. Am J Phys Med Rehabil. 2002 Aug;81(8):579-83. doi: 10.1097/00002060-200208000-00004.
• Meyer TJ, Hill NS. Noninvasive positive pressure ventilation to treat respiratory failure. Ann Intern Med. 1994 May 1;120(9):760-70. doi: 10.7326/0003-4819-120-9-199405010-00008.
• Fang G, Wan Q, Tian Y, Jia W, Luo X, Yang T, Shi Y, Gu X, Xu S. [Comparative study on pros and cons of sequential high-flow nasal cannula and non-invasive positive pressure ventilation immediately following early extubated patients with severe respiratory failure due to acute exacerbations of chronic obstructive pulmonary disease]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2021 Oct;33(10):1215-1220. doi: 10.3760/cma.j.cn121430-20210623-00939. Chinese.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: HFNC vs NIPPV

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No