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

NCT06029699 | Not Yet Recruiting

• 1 other identifier: HFNC vs NIPPV
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Respiratory Failure; Re-intubation Rate

Outcome Measures

Primary Outcomes (1)

• the need for re-intubation and weaning success which will be measured by arterial blood gas ( ABG )

  baseline

Secondary Outcomes (5)

• 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

  up to 30 days

• Incidence of any possible complications associated with the use of HFNC and NIPPV

  up to 30 days

Study Arms (2)

high flow nasal cannula group

ACTIVE COMPARATOR

patients put on high flow nasal cannula after extubation

Device: high flow nasal cannula

non invasive positive pressure ventilation group

ACTIVE COMPARATOR

patients put on non invasive positive pressure ventilation group after extubation

Device: non invasive positive pressure ventilation

Interventions

high flow nasal cannula DEVICE

device are used for weaning patients after mechanical ventilation extubation

high flow nasal cannula group

non invasive positive pressure ventilation DEVICE

device are used for weaning patients after mechanical ventilation extubation

non invasive positive pressure ventilation group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 25866645 BACKGROUND

• 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.

  PMID: 8147550 BACKGROUND

• 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.

  PMID: 28089816 BACKGROUND

• 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.

  PMID: 34955131 BACKGROUND

• 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.

  PMID: 12172066 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

mohamed osman shehata abdelkareem, resident doctor

CONTACT

+201123368743; abkmod@gmail.com

Maha Kamel Ghanem, professor

CONTACT

+201227694434; mahaghanem@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Model Details: When the patient become weanable from mechanical ventilation, the subjects were extubated immediately and randomly divided into two groups, with one group receiving HFNC (called HFNC group), the other group receiving NIPPV (called NIPPV group)

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 8, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 8, 2023

Record last verified: 2023-09