Role of High Flow Nasal Oxygen as a Strategy for Weaning From Invasive Mechan

Respiratory Failure With Hypoxia Clinical Trial

Official title:

Role of High Flow Nasal Oxygen as a Strategy for Weaning From Invasive Mechan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04657796
• Other study ID #: HFNCWEANINGMODE
• Status: Not yet recruiting
• Start date: December 5, 2020
• Est. completion date: December 4, 2023

Study information

• Verified date: December 2020
• Source: Assiut University
• Contact: Hamed Fr Qenawy, Bachelor
• Phone: 01061812045
• Email: hamedfarrag216[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

evaluate the Efficacy of high flow nasal oxygen as a weaning strategy in mechanically ventilated patients with respiratory failure.

Description:

Acute respiratory failure is a main cause of IMV and admission to intensive care unit (ICU){1}.

The day of extubation is a critical time during an intensive care unit (ICU) stay because in case of postextubation failure {2},which reach to 25 - 40% from extubated patient associated with VAP and barotrauma, mortality rate and hospital stay will increase , we use Adjuvant oxygen therapy to prevent these undesirable event like COT ,NIV and High-flow nasal cannula (HFNC) which can be used as an initial weaning strategy from IMVdue to its physiologic benefits [3-4].

HFNC devices supply between 30 and 60 L/min of a controlled mixture of actively warmed (32-37 °C) and humidified (up to 100% relative humidity) oxygen and air through modified nasal prongs. producing {5-6-7}:

1. moderate positive end-expiratory pressure (PEEP) .

2. HFNC might help prevent extubation failure through different

Mechanisms:

1. First, the controlled oxygen concentration may reduce transient hypoxemic episodes .

2. Second, the high flow washes the nasopharyngeal dead space, thus reducing CO2 re-breathing; this effect reduces respiratory rate and minute ventilation .

3. Third, the small amount of PEEP may reduce lung collapse . c)enabling better gas exchange and reduced work of breathing. d)in patients with chronic obstructive pulmonary disease (COPD), this level of PEEP may counterbalance auto PEEP, further reducing the work of breathing.

e) humidification may improve mucus drainage and reduce mucus retention, alleviating the associated atelectasis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: December 4, 2023
• Est. primary completion date: October 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1- All adult patients who were admitted to our ICU requiring endotracheal intubation (ETI), were eligible for the study.

Exclusion Criteria:

1. Non-intubated patients or those with tracheostomy were excluded from the study.

2. those having neurological alteration unrelated to hypercapnoeic encephalopathy, cranio-facial deformity, upper airway obstruction, cardiogenic pulmonary edema, cardiogenic shock, acute myocardial infarction, pneumothorax, pulmonary neoplasm, pulmonary thromboembolism, gastrointestinal bleeding, and post-operative respiratory failure.

3. Patients less than 18 y.

Related Conditions & MeSH terms

• Hypoxia
• Respiratory Failure With Hypoxia
• Respiratory Insufficiency

Intervention

Device:
• High Flow Nasal Cannula
use of high flow nasal cannula as a weaning mode from invasive mechanical ventilation to deliver oxygen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Drake MG. High-Flow Nasal Cannula Oxygen in Adults: An Evidence-based Assessment. Ann Am Thorac Soc. 2018 Feb;15(2):145-155. doi: 10.1513/AnnalsATS.201707-548FR. Review. — View Citation

Helviz Y, Einav S. A Systematic Review of the High-flow Nasal Cannula for Adult Patients. Crit Care. 2018 Mar 20;22(1):71. doi: 10.1186/s13054-018-1990-4. Review. — View Citation

Papazian L, Corley A, Hess D, Fraser JF, Frat JP, Guitton C, Jaber S, Maggiore SM, Nava S, Rello J, Ricard JD, Stephan F, Trisolini R, Azoulay E. Use of high-flow nasal cannula oxygenation in ICU adults: a narrative review. Intensive Care Med. 2016 Sep;42(9):1336-49. doi: 10.1007/s00134-016-4277-8. Epub 2016 Mar 11. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Is patient outcome in terms of survival or death at discharge.	evaluate the Efficacy of high flow nasal oxygen as a weaning strategy in mechanically ventilated patients with respiratory failure as regarding Hospitalization ,complications, oxygenation , reintubation rate, mortality rate.	through study completion average 7 days.
Secondary	Duration of ICU stay through study completion average 7 days ,Adverse events.	evaluate efficacy of high flow nasal cannula on duration of hospital stay, complications rate.	through study completion average 7 days.