Role of HVNI in Severe Chest Trauma

January 11, 2023 updated by: Mohamed Yasser Abdelgaber, Assiut University

The Role of High Velocity Nasal Insufflation in Prevention of Respiratory Complications in Severe Chest Trauma

to compare the respiratory complications in patient managed with high velocity nasal insufflation versus patients managed with conventional low flow oxygen in patients with severe chest trauma

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  • Chest trauma are associated with significant morbidity and mortality due to respiratory failure and pneumonia.
  • The two main goals of therapy are pain management and pulmonary care and support. There is strong evidence for providing good analgesia to facilitate volume expansion treatment and chest physiotherapy, aiming for deep breathing and effective cough to reduce secretions and prevent the atelectasis.
  • Oxygen supplementation is often included as supportive therapy added to bundles of care for patients of chest trauma with rib fractures.

High -velocity nasal insufflation (HVNI ) was first developed for neonates and has gained increasing use in adult patients for prevention and treatment of respiratory failure. High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered. Positive end-expiratory pressure can be generated, preventing alveoli collapse. The washout of carbon dioxide (CO2)and replacement with enriched O2 purportedly decreases work of breathing and increases breathing effectiveness.

  • Routine tests for chest injuries include chest X-rays and computed tomography (CT) scans. Ultrasound has the advantages of being inexpensive, readily available and being free of ionizing radiation .
  • In thoracic trauma cases, ultrasonography of the lungs is valuable for evaluating various chest diseases, including chest wall haematoma and fractures, pleural cavity involvement with pleural effusion, haemothorax, and pneumothorax. The ultrasound can also assess the reduce in lung aeration by changing the lung surface and generating distinct patterns as in pulmonary contusions and compression atelectasis.

Study Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chest trauma patients with lung injury confirmed by ct imaging

    • the age from 15-55 years old
    • No indication of mechanical ventilation at the time of admission to the intensive care unit

Exclusion Criteria:

  • • Patients < 15years old

    • requiring endotracheal intubation and mechanical ventilation immediately on admission for any cause
    • facial fractures or base of skull fractures
    • Who did not receive a chest computed tomography (CT) scan
    • Glasgow Coma Scale <10
    • Massive surgical emphysema
    • COPD Patients ( chronic obstructive pulmonary disease )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HVNI group
Patients will receive high velocity nasal insufflation therapy
Device: High Velocity Nasal Insufflation
High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered.
Other: Control group
Patient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask
Device: High Velocity Nasal Insufflation
High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of atelectasis in chest trauma patients
Time Frame: 3 years
Incidence of atelectasis in chest trauma patients using the chest ultrasound measured by lung consolidation score.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory complications,hospital stay and Comfort levels
Time Frame: 3 years

Other respiratory complications as hypoxemia and pneumonia.

  • Need for intubation and mechanical ventilation
  • Length of ICU and hospital stay.
  • Comfort levels with different levels of oxygen delivery measured by Likert scale.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 20, 2023

Primary Completion (Anticipated)

March 20, 2025

Study Completion (Anticipated)

September 20, 2025

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVNI in severe chest trauma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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