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

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05886998

Collaborator

(none)

100

Enrollment

Location

Arms

22.9

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Smoke Inhalation Injury Acute Lung Injury	Drug: Heparin Other: Normal Saline	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Nebulized Heparin for Prevention of Acute Lung Injury in Adult Patients Suffering Smoke Inhalation Injury: A Randomized Controlled Trial

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A (Nebulized Heparin) Heparin is nebulized via endotracheal tube	Drug: Heparin Heparin sodium (Generic, 5000 IU/ml ampoules)
Placebo Comparator: Group B (Nebulized Saline) Normal saline is nebulized via endotracheal tube	Other: Normal Saline 0.9% sodium chloride solution (normal saline) Other Names: Saline

Arm

Intervention/Treatment

Experimental: Group A (Nebulized Heparin)

Heparin is nebulized via endotracheal tube

Drug: Heparin

Heparin sodium (Generic, 5000 IU/ml ampoules)

Placebo Comparator: Group B (Nebulized Saline)

Normal saline is nebulized via endotracheal tube

Other: Normal Saline

0.9% sodium chloride solution (normal saline)

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

Occurrence of acute lung injury [28 days]
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 [28 days]
Murray Lung Injury Score >2.5

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

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.