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Status unknownNCT04657796Updated Dec 8, 2020

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

An observational study in Respiratory Failure With Hypoxia, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-12-08.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Dec 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
84
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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

Read the 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.

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Conditions studied

  • Respiratory Failure With Hypoxia
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 84 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
84 participants (estimated)
Patient registry
No

Interventions

  • DeviceHigh Flow Nasal Cannula

    use of high flow nasal cannula as a weaning mode from invasive mechanical ventilation to deliver oxygen

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion average 7 days.

Secondary outcomes

  1. 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.

    Time frame: through study completion average 7 days.

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 26969671 ↗
  • 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. PubMed 29558988 ↗
  • 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. PubMed 29144160 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04657796
Lead sponsor
Assiut University
Responsible party
Hamed Farag Qenawy Ahmed (Principal investigator, Assiut University) — Principal investigator
First posted
Dec 8, 2020
Start date
Dec 5, 2020 (estimated)
Primary completion
Oct 5, 2022 (estimated)
Completion
Dec 4, 2023 (estimated)
Last update
Dec 8, 2020

Study contacts

Hamed Fr Qenawy, Bachelor
Contact
hamedfarrag216@gmail.com
01061812045
Doaa Mo Magdy, Lecturer
Contact
doaamagdy_2020@yahoo.com
01006261010
Suzan Sl Sayed, Professor
study director · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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