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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06425627
Other study ID # TongjiHospital102114
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 20, 2024
Est. completion date May 20, 2026

Study information

Verified date May 2024
Source Tongji Hospital
Contact Tianzhu Liu, M.D.
Phone 13098866448
Email liutzh@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study was to investigate the difference in postoperative pulmonary complications (PPCs) between spinal anesthesia and general anesthesia in patients undergoing delayed hip surgery.


Description:

In this study, the difference of 30 min arterial partial pressure of oxygen after operation was used as the main outcome index. By means of pulmonary ultrasound, pulmonary function monitoring and other physical and biochemical examinations, the difference of postoperative pulmonary complications between spinal anesthesia and general anesthesia in patients with delayed operation of hip fracture longer than 48 hours was compared.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 20, 2026
Est. primary completion date May 20, 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patients = 65 years old - ASA Class I ~ III - Surgical repair of femoral neck, intertrochanteric or subtrochanteric fractures - The time from diagnosis to surgery is more than 48 hours Exclusion Criteria: - Unable to walk about 3 meters or across a room without assistance before the fracture - Emergency surgery - Chronic obstructive pulmonary disease (COPD), congestive heart failure, asthma, anemia (Hb < 90 g/L), hypoalbuminemia (ALB < 35g/L) - Abnormal coagulation function - Severe aortic stenosis - Injection site infection or increased intracranial pressure - Patients have participated in previous trials or have been determined by a surgeon or anesthesiologist to be unsuitable for randomization - The written informed consent of the patient or his/her representative cannot be obtained

Study Design


Intervention

Procedure:
spinal anesthesia
An intrathecal anesthetic technique.
general anesthesia
An intravenous (combined with inhalation) anesthetic technique.

Locations

Country Name City State
China Tianzhu Liu Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse outcomes Documented side effects associated with the intervention by an unwitting third party up to one month
Primary Arterial partial pressure of oxygen, PaO2 PaO2 was measured by arterial blood gas analysis 30 minutes after surgery
Secondary Arterial partial pressure of oxygen, PaO2 PaO2 was measured by arterial blood gas analysis 30 minutes before surgery
Secondary Forced vital capacity, FVC FVC was measured by Spirometer (SP70B) 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Secondary Forced expiratory volume in 1 second, FEV1 FEV1 was measured by Spirometer (SP70B) 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Secondary Peak expiratory flow, PEF PEF was measured by Spirometer (SP70B) 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Secondary PEF 25, 75, and 25-75 PEF 25, 75, and 25-75 were measured by Spirometer (SP70B) 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Secondary Lung Ultrasound Score (LUS) Bedside measurements using portable ultrasound 30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery
Secondary Postoperative pulmonary complications Pulmonary complications (PPCs) include: (1) Evidence of pneumonia, pneumothorax, atelectasis and pleural effusion indicated by postoperative pulmonary ultrasound, chest film or chest CT; ? After surgery, the patient developed bronchospasm, ARDS, O2 requirement (nasal catheter or mask), non-invasive ventilation requirement, or unplanned endotracheal intubation/mechanical ventilation for more than 1 day; ? The increase of inflammatory biochemical indexes 24 h after surgery suggested systemic inflammatory response (blood routine, C-reactive protein CRP, procalcitonin PCT and IL-6, IL-1ß, TNF-a). up to one month
Secondary Hip mobility (Harris hip score, HHS) The Harris scale was used to score. Range:0-100. A total Harris hip score below 70 points was considered a poor result, 70 to 80 fair, 80 to 90 good, and 90 to 100 excellent. up to one month
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