High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients

NCT06110390 | Unknown DMC

• 1 other identifier: MRC-01-18-470
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

A significant proportion of patients who are intubated for trauma-related injuries, will fail the extubation process. This means that, when the decision has been made to remove the endotracheal tube, a certain proportion of these patients will require the endotracheal tube to be re-inserted. Global estimates for the rates of re-intubation range from 5-15% of all patients who have had attempted extubation on Intensive Care Units. The exact figures for intubated victims of trauma are not available. Re-intubation is associated with increased intensive care and hospital length of stay, increased morbidity, and the physical risks to the patient inherent with the intubation process. There is also some evidence that the rates of tracheostomy are higher in patients who have failed extubation. A number of interventions have been developed to help prevent extubation failure. Non-invasive ventilation and high-flow nasal oxygen are routinely employed in practice. However, there have been no specific studies of these interventions in TICU patients. High-flow nasal oxygen therapy (HFNO) has emerged over the last decade as a viable adjunct in the management of patients suffering from, or at risk of, hypoxemic respiratory failure. Within the intensive care unit settings, HFNO has been studies in terms of preventing intubation, but it has been evaluated more often in terms of preventing extubation failure. Our study aims to answer the question of whether HFNO is effective at preventing extubation failure in intubated and ventilated victims of traumatic injuries. Previous studies on the same subject, are not based on unequivocal, robust RCTs with low risk of bias. Our primary outcome measure is re-intubation rates and secondary outcome measures are CO2 accumulation rates, atelectasis rates, nutrition status within first 24 hours post extubation, and post - extubation rates of vomiting. Ours will be a prospective, randomized clinical control study. There will be three arms to the study: a control arm, and two intervention arms. Randomization will be done on a permuted block basis. The control arm will be patients receiving standard oxygen therapy, and the intervention arms will be either High Flow Nasal Oxygen Therapy or Non-invasive Ventilation via mask. We propose that, when compared with either face-mask O2, NIV (CPAP), HFNO administered continuously for 24 hours post extubation of trauma patients on ICU, will result in better patient-related outcomes.

Conditions

Intensive Care; Airway Extubation; Critical Care; Oxygen Therapy

Outcome Measures

Primary Outcomes (1)

• Reintubation rate

  How many patients who have experienced extubation require re-intubation.

  72 hours

Secondary Outcomes (3)

• Nutritional intake achieved

  24 hours post extubation

• Post extubation rates of vomiting

  24 hours

• Amount of carbon dioxide retention

  24 hours post extubation

Study Arms (3)

High Flow Nasal Oxygen

EXPERIMENTAL

HFNO device

Device: High flow nasal oxygen

Non-invasive ventilation

EXPERIMENTAL

Non-invasive ventilation via tight-fitting facemask

Device: High flow nasal oxygen

Standard Oxygen therapy

ACTIVE COMPARATOR

Facemask oxygen is the default device used

Device: High flow nasal oxygen

Interventions

High flow nasal oxygen DEVICE

An interface applied to the nostrils allowing fresh gas flows of up to 60 liters per minute and inspired oxygen concentrations of up to an fiO2 of 1.0

Also known as: High flow nasal oxygen therapy, High flow nasal cannula

High Flow Nasal Oxygen; Non-invasive ventilation; Standard Oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult intubated and ventilated patients who are victims of trauma and are being cared for on the Trauma Intensive Care Unit will be considered eligible for the study when they are considered fit for extubation.

You may not qualify if:

• Patients who cannot be extubated (including patients requiring tracheostomy)
• Patients with cribriform plate fractures
• Patients with nasal occlusion for any reason
• Patients with unstable mid-face fractures

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad General Hospital

Doha, Qatar

RECRUITING

Study Officials

• Sandro Rizoli

  Hamad Medical Corporation

  STUDY CHAIR

Central Study Contacts

Gustav F Strandvik, MBChB

CONTACT

+97440253769; gstrandvik@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be unaware of the intervention. Data analysis performed independently to assess outcome variables
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort study. Permuted-block randomization to one of three arms

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: October 17, 2020
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)