Back to resultsNebulized Heparin for Prevention of Acute Lung Injury in Smoke Inhalation Injury
Primary Purpose
Smoke Inhalation Injury, Acute Lung Injury
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Heparin
Normal Saline
Sponsored by
About this trial
This is an interventional prevention trial for Smoke Inhalation Injury focused on measuring Smoke Inhalation Injury, Acute Lung Injury, Heparin
Eligibility Criteria
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: Burn injury > 24 hours. History of pulmonary diseases. Pregnancy or breast feeding. History of allergy to heparin or HIT. History or laboratory evidence of coagulopathy. Burns area > 50% of total body surface area. -
Sites / Locations
- Ain Shams University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A (Nebulized Heparin)
Group B (Nebulized Saline)
Arm Description
Heparin is nebulized via endotracheal tube
Normal saline is nebulized via endotracheal tube
Outcomes
Primary Outcome Measures
Occurrence of acute lung injury
Acute lung injury is defined according to the Murray Lung Injury Score which comprises 4 items: chest radiograph, PaO2/FiO2, level of PEEP and pulmonary compliance.
Each of the 4 items is assigned a score from 0 to 4. The scores are then summed up and the total score is divided by the number of scored items and is interpreted as follows:
0 = no lung injury.
0.1-2.5 = mild to moderate lung injury.
>2.5 = severe lung injury. (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. Erratum in: Am Rev Respir Dis 1989 Apr;139(4):1065. PMID: 3202424.)
Occurrence of severe acute lung injury
Murray Lung Injury Score >2.5
Secondary Outcome Measures
Duration of mechanical ventilation
Time from institution to termination of mechanical ventilation
Mortality
Survival to ICU discharge
Side effects
Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05886998
Brief Title
Nebulized Heparin for Prevention of Acute Lung Injury in Smoke Inhalation Injury
Official Title
Nebulized Heparin for Prevention of Acute Lung Injury in Adult Patients Suffering Smoke Inhalation Injury: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to examine the value of nebulized heparin for prevention of acute lung injury 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.
Occurrence of acute lung injury will be assessed everyday for a maximum of 28 days.
The primary end point is the occurrence of acute lung injury defined as defined by the Murray Lung Injury Score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoke Inhalation Injury, Acute Lung Injury
Keywords
Smoke Inhalation Injury, Acute Lung Injury, Heparin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (Nebulized Heparin)
Arm Type
Experimental
Arm Description
Heparin is nebulized via endotracheal tube
Arm Title
Group B (Nebulized Saline)
Arm Type
Placebo Comparator
Arm Description
Normal saline is nebulized via endotracheal tube
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
Heparin sodium (Generic, 5000 IU/ml ampoules)
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Saline
Intervention Description
0.9% sodium chloride solution (normal saline)
Primary Outcome Measure Information:
Title
Occurrence of acute lung injury
Description
Acute lung injury is defined according to the Murray Lung Injury Score which comprises 4 items: chest radiograph, PaO2/FiO2, level of PEEP and pulmonary compliance.
Each of the 4 items is assigned a score from 0 to 4. The scores are then summed up and the total score is divided by the number of scored items and is interpreted as follows:
0 = no lung injury.
0.1-2.5 = mild to moderate lung injury.
>2.5 = severe lung injury. (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. Erratum in: Am Rev Respir Dis 1989 Apr;139(4):1065. PMID: 3202424.)
Time Frame
28 days
Title
Occurrence of severe acute lung injury
Description
Murray Lung Injury Score >2.5
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
Description
Time from institution to termination of mechanical ventilation
Time Frame
28 days
Title
Mortality
Description
Survival to ICU discharge
Time Frame
28 days
Title
Side effects
Description
Occurrence of heparin-induced adverse effects, e.g., thrombocytopenia, abnormal bleeding
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Burn injury > 24 hours.
History of pulmonary diseases.
Pregnancy or breast feeding.
History of allergy to heparin or HIT.
History or laboratory evidence of coagulopathy.
Burns area > 50% of total body surface area. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh M Hakim, MD
Phone
+201286824970
Email
hakimsm@med.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh M Hakim, MD
Organizational Affiliation
Ain Shams University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
ZIP/Postal Code
11517
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany Eldhahaby, MD
Phone
+201227463000
Email
hanyzahaby@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
3202424
Citation
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. Erratum In: Am Rev Respir Dis 1989 Apr;139(4):1065.
Results Reference
background
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Nebulized Heparin for Prevention of Acute Lung Injury in Smoke Inhalation Injury
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