Role of HVNI in Severe Chest Trauma

NCT05692076 | Unknown

• 1 other identifier: HVNI in severe chest trauma
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chest Trauma

Keywords

High velocity nasal insufflation

Outcome Measures

Primary Outcomes (1)

• Incidence of atelectasis in chest trauma patients

  Incidence of atelectasis in chest trauma patients using the chest ultrasound measured by lung consolidation score.

  3 years

Secondary Outcomes (1)

• respiratory complications,hospital stay and Comfort levels

  3 years

Study Arms (2)

HVNI group

EXPERIMENTAL

Patients will receive high velocity nasal insufflation therapy

Device: High Velocity Nasal Insufflation

Control group

OTHER

Patient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask

Device: High Velocity Nasal Insufflation

Interventions

High Velocity Nasal Insufflation DEVICE

High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered.

Control group; HVNI group

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Karim A, Arora VK. Applications of ultrasonography in respiratory intensive care. Indian J Chest Dis Allied Sci. 2014 Jan-Mar;56(1):27-31.

  PMID: 24930204 BACKGROUND

• Easter A. Management of patients with multiple rib fractures. Am J Crit Care. 2001 Sep;10(5):320-7; quiz 328-9.

  PMID: 11548565 BACKGROUND

• McGillicuddy D, Rosen P. Diagnostic dilemmas and current controversies in blunt chest trauma. Emerg Med Clin North Am. 2007 Aug;25(3):695-711, viii-ix. doi: 10.1016/j.emc.2007.06.004.

  PMID: 17826213 BACKGROUND

• 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.

  PMID: 26969671 BACKGROUND

• 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.

  PMID: 29558988 BACKGROUND

• Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.

  PMID: 25866645 BACKGROUND

• Abdalla W, Elgendy M, Abdelaziz AA, Ammar MA. Lung ultrasound versus chest radiography for the diagnosis of pneumothorax in critically ill patients: A prospective, single-blind study. Saudi J Anaesth. 2016 Jul-Sep;10(3):265-9. doi: 10.4103/1658-354X.174906.

  PMID: 27375379 BACKGROUND

• Wongwaisayawan S, Suwannanon R, Sawatmongkorngul S, Kaewlai R. Emergency Thoracic US: The Essentials. Radiographics. 2016 May-Jun;36(3):640-59. doi: 10.1148/rg.2016150064. Epub 2016 Apr 1.

  PMID: 27035835 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Thoracic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Mohamed Yasser, Bachelor's

CONTACT

01066249910; my3939899@gmail.com

Ahmed Mandour, Consultant

CONTACT

01069996336; mando_eg_2000@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohamed yasser

Model Details: • we sought statistical advice regarding the sample size needed for the study sample size was calculated using G power program to detect significant difference. * To detect the incidence of atelectasis in these patients we performed a pilot study included 15 patients using simple mask as oxygen therapy, the results showed an incidence of 50% rate of atelectasis according to the inclusion and exclusion criteria * To be able to detect 30% reduction in the incidence of atelectasis we need to include 43 patients in each group * Alpha error=.05, 80 % power of the study with equal group assignment Group (A) :43 patients (control group): • Patient will receive conventional oxygen therapy via nasal prongs , normal oxygen mask or venturi mask Group (B) 43 patients ( HVNI group): • Patient will receive HVNI therapy

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: January 20, 2023
• Primary Completion: March 20, 2025
• Study Completion: September 20, 2025
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share