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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Nebulized Heparin) | Experimental | Heparin is nebulized via endotracheal tube |
|
| Group B (Nebulized Saline) | Placebo Comparator | Normal saline is nebulized via endotracheal tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin | Drug | Heparin sodium (Generic, 5000 IU/ml ampoules) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| VFDs | Number of days free of mechanical ventilation | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU-free days | Number of days free from ICU and alive | 28 days |
| Duration of mechanical ventilation | Time from institution to termination of mechanical ventilation |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Sameh M Hakim, MD | Ain Shams University Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Cairo Governorate | 11517 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3202424 | Background | Murray JF, Matthay MA, Luce JM, Flick MR. An expanded definition of the adult respiratory distress syndrome. Am Rev Respir Dis. 1988 Sep;138(3):720-3. doi: 10.1164/ajrccm/138.3.720. No abstract available. |
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| ID | Term |
|---|---|
| D015208 | Smoke Inhalation Injury |
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D002059 | Burns, Inhalation |
| D002056 | Burns |
| D014947 | Wounds and Injuries |
| D055370 | Lung Injury |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
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| Normal Saline |
| Other |
0.9% sodium chloride solution (normal saline) |
|
|
| 28 days |
| Mortality | Survival to ICU discharge | 28 days |
| Side effects | Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding | 28 days |
| P/F ratio | PaO2/FiO2 | 14 days |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007552 |
| Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |