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A randomized controlled trial on Perfluorohexane through intratracheal instillation for smoke inhalation injury (SII)

Perfluorohexane through intratracheal instillation for smoke inhalation injury (SII) study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004912
Enrollment
Unknown
Registered
2014-07-02
Start date
2012-05-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn associated Smoke Inhalation Injury, SII

Interventions

A:conventional treatments (CT)
B:conventional treatments (CT)

Sponsors

Affiliated hospital of the Logistic University of PAPF
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years; 2.diagnosed as burns complicated with smoke inhalation injury, and need endotracheal intubation or tracheostomy; 3. with moderately/severe smoke inhalation injury according to inhalation injury clinical classification standard; 4.voluntary participants, and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Immunosuppressed patients, including being treated with immunotherapy (Immune inhibitors, chemotherapy, radiation therapy, high-dose glucocorticoids), and with diseases affect the immune function (e.g., malignant lymphoma, leukemia,AIDS); 2. Patients with long-term and heavy smoking; 3. After Cardiopulmonary resuscitation (CPR), with serious arrhythmia or acute myocardial ischemia; 4. With one or more organ dysfunction; 5. Allergic reaction to PFC; 6. DO not accept noninvasive ventilation; 7. Pregnancy and nursing mothers; 8. APACHE II score more than 30; 9. Refuse to sign the informed consent form; 10. Other reasons that researchers think doesn't fit to participate in this study

Design outcomes

Primary

MeasureTime frame
Survival, QoL;Arterial Blood gas Analysis;Respiratory mechanics dynamic parameters;APACHE score;

Secondary

MeasureTime frame
proportions of neutrophils and macrophages in BALF;Concentrations of inflammatory factors in BALF;Concentrations of inflammatory factors in plasm;

Countries

China

Contacts

Public ContactFAN Haojun
haojunfan86@163.com+86 022-60578140

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026