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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04541758
Other study ID # ynlc201908
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 30, 2024

Study information

Verified date January 2021
Source Shanghai 6th People's Hospital
Contact Yang Li, PHD
Phone 13122109923
Email drliyang1991@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open, randomized, parallel controlled prospective clinical study design was used in this study.Subjects were patients with 2-4 displaced non-flail rib fractures.Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia.In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted.In the conservative group (group 2), routine treatment measures such as analgesia and chest strap fixed were adopted.The purpose of this study was to evaluate the safety, feasibility, and efficacy of minimally invasive and conservative treatment for rib fractures with different Numbers of displaced ends.


Description:

An open, randomized, parallel controlled prospective clinical study design type was used in this study. Subjects were patients with two to four displaced non-flail chest fractures of the ribs. Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia. In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted. In the conservative group (group 2), routine treatment measures such as analgesia, hemostasis and chest band fixation were adopted. The effects of the two treatments on lung function, pain index, complications and QoL were evaluated. It provides theoretical basis for the treatment of rib fracture


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 238
Est. completion date June 30, 2024
Est. primary completion date June 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Unilateral thoracic trauma, fractured ends of rib fractures displaced 2-4 places 2. Displaced fracture(CT image shows double displacement of bone cortex) located in the 3rd to 10th rib 3. The number of broken ends of displaced fractures is greater than that of undisplaced fractures 4. The length of time from injury to hospitalization <24 hours 5. Age range(18-70) 6. ASA grade I-II 7. BMI < 30 8. Preoperative partial arterial oxygen pressure >60mmHg, partial arterial carbon dioxide pressure <50mmHg Exclusion Criteria: 1. Difficult airway 2. History of esophageal reflux 3. Myasthenia gravis 4. Abnormal coagulation system 5. History of gastrointestinal ulcer or bleeding 6. History of anaesthesia related drug allergy A history of asthma or chronic obstructive emphysema 8. Women during pregnancy 9. Flail chest 10. Combined with severe craniocerebral trauma and external abdominal injuries 11. Recent use of clopidogrel, warfarin and aspirin seriously affects blood clotting 12. Self-administered analgesics after injury 13.Massive hemopneumothorax requires emergency surgery 14. Patients who cannot tolerate surgery -

Study Design


Intervention

Procedure:
surgical treatment
surgical treatment and Conservative treatment
Conservative treatment
Conservative treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai 6th People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage improvement of lung function FEV1(Forced expiratory volume in one second) FEV1(Forced expiratory volume in one second),FEV1% :percentage of the expected value FEV1%(One week after treatment)-FEV1%(Admitted)
Secondary Percentage improvement of lung function FVC FVC(forced vital capacity),FVC%:percentage of the expected value FVC%(One week after treatment)-FVC%(Admitted)
Secondary Percentage improvement of lung function PEF PEF(peak expiratory flow ),PEF%:percentage of the expected value PEF%(One week after treatment)-PEF%(Admitted)
Secondary Pain index visual analogue scale,VAS(0-10)0:no pain;10:severe pain Admitted;One week after treatment;One month after treatment;Three month after treatment;Half a year;One year
Secondary Pleural effusion Measured by chest CT Admitted;One week after treatment;One month after treatment;Three month after treatment;Half a year;One year
Secondary Mortality rate Deaths associated with this study Admitted;One week after treatment;One month after treatment;Three month after treatment;Half a year;One year
Secondary Length of hospital stay Length of hospital stay Admitted;One week after treatment;One month after treatment;Three month after treatment;Half a year;One year
Secondary Cost of treatment Sum of all treatment costs One year
Secondary Chronic pain Pain lasting more than three months(It is suggested in the related article that pain lasting more than 3 months is chronic pain)visual analogue scale,VAS(0-10)0:no pain;10:severe pain Three month after treatment;Half a year;One year
Secondary Quality of Life score The Barthel index of ADL One week after treatment;One month after treatment;Three month after treatment;Half a year;One year
Secondary Time to resume routine work Time to resume routine work One week after treatment;One month after treatment;Three month after treatment;Half a year;One year
Secondary Duration of analgesic medication Duration of analgesic medication intraoperative;One week after treatment;One month after treatment;Three month after treatment;Half a year;One year
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