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

• ClinicalTrials.gov Identifier: NCT04657796
• Recruitment Status: Not yet recruiting
• First Posted: December 8, 2020
• Last Update Posted: December 8, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): Hamed Farag Qenawy Ahmed, Assiut University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Respiratory Failure With Hypoxia	Device: High Flow Nasal Cannula

Detailed 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 84 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Role of High Flow Nasal Oxygen as a Strategy for Weaning From Invasive Mechan
• Estimated Study Start Date: December 5, 2020
• Estimated Primary Completion Date: October 5, 2022
• Estimated Study Completion Date: December 4, 2023

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. Is patient outcome in terms of survival or death at discharge. [ Time Frame: through study completion average 7 days. ]
   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.

Secondary Outcome Measures :

1. Duration of ICU stay through study completion average 7 days ,Adverse events. [ Time Frame: through study completion average 7 days. ]
   evaluate efficacy of high flow nasal cannula on duration of hospital stay, complications rate.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

all patient in respiratory ICU who mechanically intubated will be enrolled in study by using high flow nasal oxygen as a weaning strategy.

Criteria

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.

Contacts and Locations

Contacts

Contact: Hamed Fr Qenawy, Bachelor; 01061812045; hamedfarrag216@gmail.com

Contact: Doaa Mo Magdy, Lecturer; 01006261010; doaamagdy_2020@yahoo.com

Sponsors and Collaborators

Assiut University

Investigators

• Study Director: Suzan Sl Sayed, Professor; Assiut University

More Information

Publications of Results:

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.

Other Publications:

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.

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.

• Responsible Party: Hamed Farag Qenawy Ahmed, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04657796
• Other Study ID Numbers: HFNCWEANINGMODE
• First Posted: December 8, 2020
• Last Update Posted: December 8, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Respiratory Insufficiency; Hypoxia; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory