Clinical trial NCT05758870: A Prospective Randomized Controlled Study Comparing the Clinical Effects of Surgical and Non-surgical Treatment of Low Rib Fractures
Official title: Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rib Fracture Multiple
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with multiple rib fractures combines with low rib fractures

Brief summary: The purpose of this study is to explore the difference between the clinical effects of surgical and non-surgical treatment for patients with low rib fracture, and to explore whether SSRF has more clinical treatment advantages in patients with low rib fracture in a randomized, controlled and prospective manner.


Eligibility criteria: Inclusion Criteria:

* Patients with chest trauma only and unilateral low rib fractures Three rib fractures and more Displacement of the broken end of the fracture (bicortical fracture and not in the same line) Time from injury to hospital \< 24 hours Age 18-70 ASA grade I-II Preoperative arterial oxygen partial pressure \>60mmHg, carbon dioxide partial pressure \<50mmHg The participate is volunteer in the study and sign the informed consent Pain score( Number Rating Scale, NRS) \>5 under calm breathing

Exclusion Criteria:

* Difficult airway History of esophageal reflux Myasthenia gravis Coagulation disorders Gastrointestinal ulcer Gastrointestinal bleeding Anesthetic drugs allergy history Asthma Chronic obstructive pulmonary disease Pregnant women

Primary outcomes:
measure: EQ-5D-5L
timeFrame: On the day of admission
measure: EQ-5D-5L
timeFrame: 1 week after treatment
measure: EQ-5D-5L
timeFrame: 2 weeks after treatment
measure: EQ-5D-5L
timeFrame: 1 month after treatment
measure: EQ-5D-5L
timeFrame: 3 months after treatment
measure: EQ-5D-5L
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Pain Score
timeFrame: On the day of admission
measure: Pain Score
timeFrame: 1 week after treatment
measure: Pain Score
timeFrame: 2 weeks after treanment
measure: Pain Score
timeFrame: 1 month after treatment
measure: Pain Score
timeFrame: 3 months after treatment
measure: Pain Score
timeFrame: 6 months after treatment
Other outcomes:
measure: Atelectasis
timeFrame: On the day of admission
measure: Atelectasis
timeFrame: 1 week after treatment
measure: Atelectasis
timeFrame: 2 weeks after treanment
measure: Atelectasis
timeFrame: 1 month after treatment
measure: Atelectasis
timeFrame: 3 months after treatment
measure: Atelectasis
timeFrame: 6 months after treatment
measure: Pleural effusion
timeFrame: On the day of admission
measure: Pleural effusion
timeFrame: 1 week after treatment
measure: Pleural effusion
timeFrame: 2 weeks after treanment
measure: Pleural effusion
timeFrame: 1 months after treatment
measure: Pleural effusion
timeFrame: 3 months after treatment
measure: Pleural effusion
timeFrame: 6 months after treatment
measure: Mortality
timeFrame: On the day of admission
measure: Mortality
timeFrame: 1 week after treatment
measure: Mortality
timeFrame: 2 weeks after treanment
measure: Mortality
timeFrame: 1 month after treatment
measure: Mortality
timeFrame: 3 months after treatment
measure: Mortality
timeFrame: 6 months after treatment
measure: Length of hospital stay
timeFrame: the day from in the hospital to discharge
measure: Cost of treatment
timeFrame: the day from in the hospital to discharge
measure: Chest discomfort
timeFrame: On the day of admission
measure: Chest discomfort
timeFrame: 1 week after treatment
measure: Chest discomfort
timeFrame: 2 weeks after treanment
measure: Chest discomfort
timeFrame: 1 month after treatment
measure: Chest discomfort
timeFrame: 3 months after treatment
measure: Chest discomfort
timeFrame: 6 months after treatment
measure: Chronic pain
timeFrame: 3 months after treatment , 6 month after treatment
measure: Chronic pain
timeFrame: 6 months after treatment
measure: Duration of analgesic drug
timeFrame: the time of analgesic usement from first treat to the paitent do not use it anymore
measure: Total analgesic drug use
timeFrame: the time of analgesic usement from first treat to the paitent do not use it anymore
measure: Lung function 1
timeFrame: On the day of admission
measure: Lung function 1
timeFrame: 1 week after treatment
measure: Lung function 1
timeFrame: 2 weeks after treanment
measure: Lung function 1
timeFrame: 1 month after treatment
measure: Lung function 1
timeFrame: 3 months after treatment
measure: Lung function 1
timeFrame: 6 months after treatment
measure: Lung function 2
timeFrame: On the day of admission
measure: Lung function 2
timeFrame: 1 week after treatment
measure: Lung function 2
timeFrame: 2 weeks after treanment
measure: Lung function 2
timeFrame: 1 month after treatment
measure: Lung function 2
timeFrame: 3 months after treatment
measure: Lung function 2
timeFrame: 6 months after treatment
Locations:
Study officials:
References: