Pulmonary ComplicationNCT06425627
Spinal Versus General Anesthesia on Postoperative Pulmonary Complications
A study testing spinal anesthesia and general anesthesia in people with Pulmonary Complication and Anesthesia, run by Tongji Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pulmonary Complication, Anesthesia, Hip Fractures
- What is being tested?
- spinal anesthesia and general anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2024to 20 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Unable to walk about 3 meters or across a room without assistance before the fracture
- Emergency surgery
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianzhu Liu
Wuhan, Hubei, 430000
Tianzhu Liu, M.D., 13098866448, liutzh@126.com
Tianzhu Liu, M.D.
About this study
Official title: Spinal Versus General Anesthesia on Postoperative Pulmonary Complications in Elderly Patients With Delayed Operation of Hip Fracture
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.
Read the detailed 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.
- Conditions
- Pulmonary Complication, Anesthesia, Hip Fractures
- Being tested
- spinal anesthesia, general anesthesia
- Keywords
- Hip fracture, delayed surgery, pulmonary complication, spinal anesthesia, general anesthesia
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
Also called lumbar anesthesia
An intrathecal anesthetic technique.
general anesthesiaProcedure or surgery
An intravenous (combined with inhalation) anesthetic technique.
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia | Experimental | Patients underwent real-time ultrasound guided spinal anesthesia. The maximum attempts of skin piercings are 3, and the total redirections of each skin piercings should not exceed 6 times. General anesthesia was considered if three skin piercings were unsuccessful. Receives: Procedure: spinal anesthesia |
| general anesthesia | Experimental | Rapid sequential induction was performed with sufentanil 0.5 ug /kg, etomidate 0.3 mg /kg, cisatracurium 0.15 mg /kg, and then laryngeal mask was applyed. Parameter settings: tidal volume: 6-10 mL/kg, 1.5 ~ 2.0% sevoflurane inhalation, remifentanil 0.1 ~ 0.2 ug/ kg.min-1. Mechanical driving pressure was applyed by PEEP titration method. Receives: Procedure: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial partial pressure of oxygen, PaO2
PaO2 was measured by arterial blood gas analysis
Measured: 30 minutes after surgery
Secondary outcomes (8)
Arterial partial pressure of oxygen, PaO2
PaO2 was measured by arterial blood gas analysis
Measured: 30 minutes before surgery
Forced vital capacity, FVC
FVC was measured by Spirometer (SP70B)
Measured: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Forced expiratory volume in 1 second, FEV1
FEV1 was measured by Spirometer (SP70B)
Measured: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Peak expiratory flow, PEF
PEF was measured by Spirometer (SP70B)
Measured: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
PEF 25, 75, and 25-75
PEF 25, 75, and 25-75 were measured by Spirometer (SP70B)
Measured: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Lung Ultrasound Score (LUS)
Bedside measurements using portable ultrasound
Measured: 30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery
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; ② 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; ③ 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-1β, TNF-α).
Measured: up to one month
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.
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start12 Jun 2024
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tianzhu Liu, Tongji Hospital
- Investigators
- Tianzhu Liu, M.D., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425627
- Sponsor's protocol ID
- TongjiHospital102114
- Status last verified
- Sep 2025
- First submitted
- 9 May 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Versus General Anesthesia on Postoperative Pulmonary Complications in Elderly Patients With Delayed Operation of Hip Fracture
- ClinicalTrials.gov ID
- NCT06425627
- Acronym / sponsor ID
- TongjiHospital102114
- Conditions
- Pulmonary Complication, Anesthesia, Hip Fractures
- Keywords
- Hip fracture, delayed surgery, pulmonary complication, spinal anesthesia, general anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia | Experimental | Procedure: spinal anesthesiaPatients underwent real-time ultrasound guided spinal anesthesia. The maximum attempts of skin piercings are 3, and the total redirections of each skin piercings should not exceed 6 times. General anesthesia was considered if three skin piercings were unsuccessful. |
| general anesthesia | Experimental | Procedure: general anesthesiaRapid sequential induction was performed with sufentanil 0.5 ug /kg, etomidate 0.3 mg /kg, cisatracurium 0.15 mg /kg, and then laryngeal mask was applyed. Parameter settings: tidal volume: 6-10 mL/kg, 1.5 ~ 2.0% sevoflurane inhalation, remifentanil 0.1 ~ 0.2 ug/ kg.min-1. Mechanical driving pressure was applyed by PEEP titration method. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Unable to walk about 3 meters or across a room without assistance before the fracture
- Emergency surgery
- Congestive heart failure, asthma, anemia (Hb < 90 g/L), hypoalbuminemia (ALB < 35g/L)
- Abnormal coagulation function
- Severe aortic stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesiaAlso: lumbar anesthesiaAn intrathecal anesthetic technique. | Procedure or surgery | spinal anesthesia |
| general anesthesiaAn intravenous (combined with inhalation) anesthetic technique. | Procedure or surgery | general anesthesia |
Primary outcome
Arterial partial pressure of oxygen, PaO2
Time frame: 30 minutes after surgery
PaO2 was measured by arterial blood gas analysis
8 secondary outcomes
Arterial partial pressure of oxygen, PaO2
Time frame: 30 minutes before surgery
Forced vital capacity, FVC
Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Forced expiratory volume in 1 second, FEV1
Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Peak expiratory flow, PEF
Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
PEF 25, 75, and 25-75
Time frame: 30 minutes before surgery; 30 minutes after surgery; 24 hours after surgery
Lung Ultrasound Score (LUS)
Time frame: 30 minutes before surgery, 30 minutes after surgery, 24 hours after surgery
Postoperative pulmonary complications
Time frame: up to one month
Hip mobility (Harris hip score, HHS)
Time frame: up to one month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tianzhu Liu, M.D. principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia and general anesthesia in people with Pulmonary Complication and Anesthesia, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianzhu Liu, M.D. (13098866448, liutzh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial partial pressure of oxygen, PaO2 (time frame: 30 minutes after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.