Nebulized Heparin for Prevention of Acute Lung Injury in Smoke Inhalation Injury

Phase 3

Completed

• Conditions: Smoke Inhalation Injury; Acute Lung Injury
• Interventions: Drug: Heparin; Other: Normal Saline

• Registration Number: NCT05886998
• Lead Sponsor: Ain Shams University

Brief Summary

This study aims to examine the effects of nebulized heparin on the clinical outcomes in adult patients suffering smoke inhalation injury.

Patients will be randomized to receive nebulized heparin or an equal volume of normal saline for 14 days and the incidence of acute lung injury will be compared in either group.

Detailed Description

Adult patients who suffered smoke inhalation injury and who are candidates for elective intubation, have evidence of bronchial burn by fiberoptic bronchoscopy, have no evidence of acute lung injury and no more than 24 hours since inhalation injury will be included.

Patients will be randomized into 2 groups:

Group A (Intervention): Patients will receive 5000 IU heparin mixed with 3 ml saline and nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier.

Group B (Control): Patients will receive 4 ml of normal saline nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier.

The primary end point is the VFDs.

Study Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-31
• Study Start: 2023-06-01
• Study First Posted: 2023-06-02
• Primary Completion: 2024-06-03
• Study Completion: 2024-06-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Adult patients indicated for elective intubation:

• History of being trapped in a house or industrial fire.

• Production of carbonaceous sputum.

• Perioral facial burns affecting nose, lips, mouth, or throat .

• Altered level of consciousness at any time after the incident and including confusion.

• Symptoms of respiratory distress including a sense of suffocation, choking, breathlessness, and wheezing or discomfort affecting the eyes or throat, including irritation of the mucosal membranes.

• Signs of respiratory distress including stertorous or labored breathing, and tachypnea or auscultatory abnormalities, including crepitations or rhonchi.

• Hoarseness or loss of voice. 2. Evidence of bronchial burn by bronchoscopy to assess severity of inhalational trauma

• NO injury: absence of carbonaceous deposits, erythema, oedema, brochorrhea, or obstruction.

• Mild injury: minor patchy areas of erythema or carbonaceous deposits in proximal or distal bronchi.

• Moderate injury: moderate degree of erythema, carbonaceous deposits, bronchorrhea, or bronchial obstructions.

• Sever injury: sever inflammation with friability, copious carbonaceous deposits, bronchorrhea, or obstruction.

• Massive injury: evidence of mucosal sloughing, necrosis or endoluminal obliteration.

  3. No evidence of acute lung injury at presentation (either by radiology or ABG)

• Radiological findings: Normal lung without increased interstitial markings, ground glass opacification, or consolidation.

• ABG findings : PaO2/ Fio2 > 300. 4. Time between inhalational injury and intubation not longer than 24 hours.

Exclusion Criteria

1. Burn injury > 24 hours.
2. History of pulmonary diseases.
3. Pregnancy or breast feeding.
4. History of allergy to heparin or HIT.
5. History or laboratory evidence of coagulopathy.
6. Burns area > 50% of total body surface area. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Nebulized Heparin)	Heparin	Heparin is nebulized via endotracheal tube
Group B (Nebulized Saline)	Normal Saline	Normal saline is nebulized via endotracheal tube

Primary Outcome Measures

Name	Time	Method
VFDs	28 days	Number of days free of mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
ICU-free days	28 days	Number of days free from ICU and alive
Duration of mechanical ventilation	28 days	Time from institution to termination of mechanical ventilation
Mortality	28 days	Survival to ICU discharge
Side effects	28 days	Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding
P/F ratio	14 days	PaO2/FiO2

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt