Ventilator-associated Lung InjuryNCT06021249
Comparing Innovative and Traditional Ventilation Strategies on Atelectasis and Prognosis in Elderly Patients
A study testing Traditional ventilation strategies, Traditional lung-protective ventilation strategies and Innovative lung-protective ventilation strategies in people with Ventilator-associated Lung Injury and Atelectasis, run by Fujian Medical University Union Hospital at 3 sites in China.
Trial summary
This study was divided into two parts, taking elderly patients undergoing general anesthesia surgery as the research subjects, through factorial design: 1. It was verified that in elderly patients undergoing general anesthesia surgery, innovative lung-protective ventilation strategies can reduce the occurrence of… Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Ventilator-associated Lung Injury, Atelectasis, Postoperative Pulmonary Complications
- What is being tested?
- Traditional ventilation strategies, Traditional lung-protective ventilation strategies and Innovative lung-protective ventilation strategies
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 3 sitesChina
- Study dates
- 28 Sep 2021to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients aged ≥ 60 years old who undergo laparoscopic abdominal surgery；
- Body mass index（BMI） <30；
- American society of anesthesiologists physical status classification system（ASA）:I-III；
- When the patient inhales air before surgery, SPO2≥94%；
- The duration of the operation is 2-7 hours, and the pneumoperitoneal pressure is 10-14mmHg.
Who cannot join
- Patients with acute respiratory distress syndrome or pulmonary hypertension (pulmonary systolic blood pressure ≥ 40mmHg) or bronchiectasis or lung malignant tumors
- Patients with acute respiratory infections within one month before surgery
- Patients who have undergone cardiopulmonary surgery
- Receiving invasive mechanical ventilation for more than 30min within 30 days before surgery
- Patients with peak airway pressure > 35 cm H2O during intraoperative mechanical ventilation
- Patients with severe organic lesions of the heart such as obvious heart failure and coronary heart disease
Show all 13Show fewer
- Patients with preoperative anemia (Hb<10g/L)
- Patients with hypoproteinemia before surgery (albumin < 35 g/L)
- Patients with tracheostomy and severe difficult airway
- Patients with sleep apnea syndrome
- Patients with intraoperative heavy bleeding (50% of the circulating blood volume is lost ≥ 3 hours)
- Patients with mental illness, impaired consciousness and communication disorders
- Patients who refuse to participate in this trial
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Lingli Pan, +86 18065184976, panlin199104@163.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Jia Min, +86 13970899291, candymin66@163.com
- Not yet recruiting
The First Hospital of Putian
Putian, Fujian
Huan Chen, +86 15080007150, flyupinsky@163.com
About this study
Official title: Comparing the Effects of Innovative and Traditional Lung-protective Ventilation Strategies on the Occurrence of Perioperative Atelectasis and Prognosis in Elderly Patients: a Prospective, Randomized, Controlled Study
This study was divided into two parts, taking elderly patients undergoing general anesthesia surgery as the research subjects, through factorial design: 1. It was verified that in elderly patients undergoing general anesthesia surgery, innovative lung-protective ventilation strategies can reduce the occurrence of atelectasis and reduce the incidence of ventilator-related lung injury and postoperative pulmonary complications more than traditional lung-protective ventilation strategies; 2. On the basis of part one study proving that innovative lung-protective ventilation strategies can reduce the incidence of postoperative atelectasis and other complications in elderly patients undergoing general anesthesia surgery compared with traditional lung-protective ventilation strategies, further comparisons were made between the two factors of "positive pressure extubation" and "improved early postoperative respiratory training" in the innovative lung protective ventilation strategy, and whether there was an interaction between the two.
Read the detailed description
More and more people need to undergo general anesthesia surgery at least once in the lifetime, and patients who undergo general anesthesia surgery often have postoperative pulmonary complications, and the occurrence of postoperative pulmonary complications is related to the prolongation of the patient's hospital stay and postoperative mortality. This is contrary to the current goal of rapid postoperative recovery.
The International Expert Consensus on Strategies for Pulmonary Protective Ventilation states that age > 50 years is one of the greatest risk factors for postoperative pulmonary complications. This means that even older patients with largely unimpaired preoperative lung function are more likely to develop postoperative pulmonary complications than younger patients. Therefore, the investigators set the study to elderly patients undergoing general anesthesia surgery.
The traditional lung-protective ventilation strategies commonly used to reduce atelectasis and ventilator-related lung injury during general anesthesia surgery is controversial and mixed. Based on literature review and preliminary experiments, this study focuses on extubation and post-extubation, which is a critical period of atelectasis development, combines positive pressure extubation technology with improved postoperative early breathing training, replaces the controversial continuous positive airway pressure（CPAP）support and alveolar recruitment manoeuvres in traditional lung protective ventilation strategies, and explores a new respiratory management strategy with more operability and clinical effect to reduce complications such as postoperative atelectasis in elderly patients.
This study was originally a single-center clinical study and has been registered in the Chinese Clinical Trial Registry（Registration number：ChiCTR2300071364）. It was later changed to a multi-center clinical study, so it was re-registered.
- Being tested
- Traditional ventilation strategies, Traditional lung-protective ventilation strategies, Innovative lung-protective ventilation strategies, Lung-protective ventilation, negative pressure extubation
- Keywords
- perioperative strategies for lung-protective ventilation, elderly patients, atelectasis, postoperative pulmonary complications, lung injury
- Medical subject headings
- Pulmonary Atelectasis, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ventilation strategiesProcedure or surgery
- Tidal volume：10ml/kg predicted body weight（PBW）；
- 0 cm H2O positive end expiratory pressure（PEEP）；
- negative pressure extubation
Traditional lung-protective ventilation strategiesProcedure or surgery
- Tidal volume：6ml/kg PBW；
- 5cmH2O PEEP；
- Ventilator-controlled recruitment manoeuvre；
- CPAP；
- negative pressure extubation
Innovative lung-protective ventilation strategiesProcedure or surgery
- Tidal volume：6ml/kg PBW；
- 5cmH2O PEEP；
- positive pressure extubation；
- postoperative breathing training
Lung-protective ventilationProcedure or surgery
- Tidal volume：6ml/kg PBW；
- 5cmH2O PEEP；
negative pressure extubationProcedure or surgery
The suction tube is inserted into the endotracheal tube, continuous negative pressure suction, and at the same time that the balloon is completely deflated, the suction tube, dental pad and endotracheal intubation are pulled out at the same time, and then the patient is instructed to cough independently and remove sputum.
positive pressure extubationProcedure or surgery
The adjustable pressure limiting（APL）was adjusted to 30cm H2O, and after the patient breathed spontaneously until the peak airway pressure reached 30cm H2O, and after maintaining this level for 10s, the balloon was quickly cut off to remove the endotracheal tube, so that the patient had an autonomous coughing action, and then the oral sputum was removed.
postoperative breathing trainingProcedure or surgery
Inhale deeply through the nose, hold the breath for 5s, and then slowly spit out the breath through the mouth, cycle 5-6 times, and inflate the balloon. The above steps need to be performed 15 times within 24 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group of Control (Part I experiment) | Sham comparator | Traditional ventilation strategies Receives: Procedure: Traditional ventilation strategies |
| Group of traditional lung-protective ventilation (Part I experiment) | Experimental | Traditional lung-protective ventilation strategies Receives: Procedure: Traditional lung-protective ventilation strategies |
| Group of innovative lung-protective ventilation (Part I experiment) | Experimental | Innovative lung-protective ventilation strategies Receives: Procedure: Innovative lung-protective ventilation strategies |
| Group of traditional & innovative ventilation (Part I experiment) | Experimental | Traditional \& innovative lung protection ventilation strategies Receives: Procedure: Traditional lung-protective ventilation strategies; Procedure: Innovative lung-protective ventilation strategies |
| Group of Control (Part II experiment) | Sham comparator | 1. lung-protective ventilation；
2. negative pressure extubation Receives: Procedure: Lung-protective ventilation; Procedure: negative pressure extubation |
| Group of positive pressure extubation (Part II experiment) | Experimental | 1. lung-protective ventilation；
2. positive pressure extubation Receives: Procedure: Lung-protective ventilation; Procedure: positive pressure extubation |
| Group of breathing training (Part II experiment) | Experimental | 1. lung-protective ventilation；
2. negative pressure extubation；
3. postoperative breathing training Receives: Procedure: Lung-protective ventilation; Procedure: negative pressure extubation; Procedure: postoperative breathing training |
| Group of positive pressure extubation & breathing training (Part II experiment) | Experimental | 1. lung-protective ventilation；
2. positive pressure extubation；
3. postoperative breathing training Receives: Procedure: Lung-protective ventilation; Procedure: positive pressure extubation; Procedure: postoperative breathing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume ratio of new-onset atelectasis after surgery
After lung CT examination, the postoperative volume ratio of new atelectasis (new atelectasis volume/total lung volume) was calculated.
Measured: Pre-surgery;Approximately 24 hours after surgery
Secondary outcomes (3)
postoperative pulmonary complications
Diagnosis according to the US Centers for Disease Control definition of pneumonia:
Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease):
(i) New or progressive and persistent infiltrates, (ii)consolidation, (iii) cavitation;
AND at least one of the following:
- fever (>38°C) with no other recognised cause,
- leucopaenia (white cell count <4*10^9/ litre) or leucocytosis(white cell count >12*10^9 /litre),
- for adults >70 years old, altered mental status with no other recognised cause;
AND at least two of the following:
- new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements,
- new onset or worsening cough, or dyspnoea, or tachypnoea,
- rales or bronchial breath sounds,
- worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).
Measured: Within 14 days after surgery; Within 30 days after surgery
specific indexes of ventilator-related lung injury
Blood was drawn and centrifuged for serum ELISA to detect landmark indicators of ventilator-related lung injury
Measured: Pre-surgery;Immediately after the extubation;Approximately 24 hours after surgery
oxygenation index
Arterial blood samples are drawn for blood gas analysis
Measured: Pre-surgery;20 minutes after the intubation;End of the operation;Approximately 10 minutes after the extubation;Approximately 40 minutes after the extubation;Approximately 70 minutes after the extubation;Approximately 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start28 Sep 2021
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-associated Lung InjuryStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University, The First Hospital of Putian City, Putian, Fujian
- Responsible party
- Sponsor
- Investigators
- Zhongmeng Lai, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021249
- Sponsor's protocol ID
- 2021MZK04KY
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In June 2024, raw data was shared through ResMan（http://www.medresman.org.cn/login.aspx）
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Innovative and Traditional Lung-protective Ventilation Strategies on the Occurrence of Perioperative Atelectasis and Prognosis in Elderly Patients: a Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06021249
- Acronym / sponsor ID
- 2021MZK04KY
- Keywords
- perioperative strategies for lung-protective ventilation, elderly patients, atelectasis, postoperative pulmonary complications, lung injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University, The First Hospital of Putian City, Putian, Fujian
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 1 Sep 2023 (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.
This study was divided into two parts, taking elderly patients undergoing general anesthesia surgery as the research subjects, through factorial design: 1. It was verified that in elderly patients undergoing general anesthesia surgery, innovative lung-protective ventilation strategies can reduce the occurrence of atelectasis and reduce the incidence of ventilator-related lung injury and postoperative pulmonary complications more than traditional lung-protective ventilation strategies; 2. On the basis of part one study proving that innovative lung-protective ventilation strategies can reduce the incidence of postoperative atelectasis and other complications in elderly patients undergoing general anesthesia surgery compared with traditional lung-protective ventilation strategies, further comparisons were made between the two factors of "positive pressure extubation" and "improved early postoperative respiratory training" in the innovative lung protective ventilation strategy, and whether there was an interaction between the two.
Detailed description
More and more people need to undergo general anesthesia surgery at least once in the lifetime, and patients who undergo general anesthesia surgery often have postoperative pulmonary complications, and the occurrence of postoperative pulmonary complications is related to the prolongation of the patient's hospital stay and postoperative mortality. This is contrary to the current goal of rapid postoperative recovery.
The International Expert Consensus on Strategies for Pulmonary Protective Ventilation states that age > 50 years is one of the greatest risk factors for postoperative pulmonary complications. This means that even older patients with largely unimpaired preoperative lung function are more likely to develop postoperative pulmonary complications than younger patients. Therefore, the investigators set the study to elderly patients undergoing general anesthesia surgery.
The traditional lung-protective ventilation strategies commonly used to reduce atelectasis and ventilator-related lung injury during general anesthesia surgery is controversial and mixed. Based on literature review and preliminary experiments, this study focuses on extubation and post-extubation, which is a critical period of atelectasis development, combines positive pressure extubation technology with improved postoperative early breathing training, replaces the controversial continuous positive airway pressure（CPAP）support and alveolar recruitment manoeuvres in traditional lung protective ventilation strategies, and explores a new respiratory management strategy with more operability and clinical effect to reduce complications such as postoperative atelectasis in elderly patients.
This study was originally a single-center clinical study and has been registered in the Chinese Clinical Trial Registry（Registration number：ChiCTR2300071364）. It was later changed to a multi-center clinical study, so it was re-registered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group of Control (Part I experiment) | Sham comparator | Procedure: Traditional ventilation strategiesTraditional ventilation strategies |
| Group of traditional lung-protective ventilation (Part I experiment) | Experimental | Procedure: Traditional lung-protective ventilation strategiesTraditional lung-protective ventilation strategies |
| Group of innovative lung-protective ventilation (Part I experiment) | Experimental | Procedure: Innovative lung-protective ventilation strategiesInnovative lung-protective ventilation strategies |
| Group of traditional & innovative ventilation (Part I experiment) | Experimental | Procedure: Traditional lung-protective ventilation strategies, Procedure: Innovative lung-protective ventilation strategiesTraditional \& innovative lung protection ventilation strategies |
| Group of Control (Part II experiment) | Sham comparator | Procedure: Lung-protective ventilation, Procedure: negative pressure extubation1. lung-protective ventilation； 2. negative pressure extubation |
| Group of positive pressure extubation (Part II experiment) | Experimental | Procedure: Lung-protective ventilation, Procedure: positive pressure extubation1. lung-protective ventilation； 2. positive pressure extubation |
| Group of breathing training (Part II experiment) | Experimental | Procedure: Lung-protective ventilation, Procedure: negative pressure extubation, Procedure: postoperative breathing training1. lung-protective ventilation； 2. negative pressure extubation； 3. postoperative breathing training |
| Group of positive pressure extubation & breathing training (Part II experiment) | Experimental | Procedure: Lung-protective ventilation, Procedure: positive pressure extubation, Procedure: postoperative breathing training1. lung-protective ventilation； 2. positive pressure extubation； 3. postoperative breathing training |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elderly patients aged ≥ 60 years old who undergo laparoscopic abdominal surgery；
- Body mass index（BMI） <30；
- American society of anesthesiologists physical status classification system（ASA）:I-III；
- When the patient inhales air before surgery, SPO2≥94%；
- The duration of the operation is 2-7 hours, and the pneumoperitoneal pressure is 10-14mmHg.
Key exclusion criteria (13 listed)
- Patients with acute respiratory distress syndrome or pulmonary hypertension (pulmonary systolic blood pressure ≥ 40mmHg) or bronchiectasis or lung malignant tumors
- Patients with acute respiratory infections within one month before surgery
- Patients who have undergone cardiopulmonary surgery
- Receiving invasive mechanical ventilation for more than 30min within 30 days before surgery
- Patients with peak airway pressure > 35 cm H2O during intraoperative mechanical ventilation
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 |
|---|---|---|
| Traditional ventilation strategies1. Tidal volume：10ml/kg predicted body weight（PBW）； 2. 0 cm H2O positive end expiratory pressure（PEEP）； 3. negative pressure extubation | Procedure or surgery | Group of Control (Part I experiment) |
| Traditional lung-protective ventilation strategies1. Tidal volume：6ml/kg PBW； 2. 5cmH2O PEEP； 3. Ventilator-controlled recruitment manoeuvre； 4. CPAP； 5. negative pressure extubation | Procedure or surgery | Group of traditional & innovative ventilation (Part I experiment), Group of traditional lung-protective ventilation (Part I experiment) |
| Innovative lung-protective ventilation strategies1. Tidal volume：6ml/kg PBW； 2. 5cmH2O PEEP； 3. positive pressure extubation； 4. postoperative breathing training | Procedure or surgery | Group of innovative lung-protective ventilation (Part I experiment), Group of traditional & innovative ventilation (Part I experiment) |
| Lung-protective ventilation1. Tidal volume：6ml/kg PBW； 2. 5cmH2O PEEP； | Procedure or surgery | Group of Control (Part II experiment), Group of breathing training (Part II experiment), Group of positive pressure extubation & breathing training (Part II experiment), Group of positive pressure extubation (Part II experiment) |
| negative pressure extubationThe suction tube is inserted into the endotracheal tube, continuous negative pressure suction, and at the same time that the balloon is completely deflated, the suction tube, dental pad and endotracheal intubation are pulled out at the same time, and then the patient is instructed to cough independently and remove sputum. | Procedure or surgery | Group of Control (Part II experiment), Group of breathing training (Part II experiment) |
| positive pressure extubationThe adjustable pressure limiting（APL）was adjusted to 30cm H2O, and after the patient breathed spontaneously until the peak airway pressure reached 30cm H2O, and after maintaining this level for 10s, the balloon was quickly cut off to remove the endotracheal tube, so that the patient had an autonomous coughing action, and then the oral sputum was removed. | Procedure or surgery | Group of positive pressure extubation & breathing training (Part II experiment), Group of positive pressure extubation (Part II experiment) |
| postoperative breathing trainingInhale deeply through the nose, hold the breath for 5s, and then slowly spit out the breath through the mouth, cycle 5-6 times, and inflate the balloon. The above steps need to be performed 15 times within 24 hours after surgery. | Procedure or surgery | Group of breathing training (Part II experiment), Group of positive pressure extubation & breathing training (Part II experiment) |
Primary outcome
Volume ratio of new-onset atelectasis after surgery
Time frame: Pre-surgery;Approximately 24 hours after surgery
After lung CT examination, the postoperative volume ratio of new atelectasis (new atelectasis volume/total lung volume) was calculated.
3 secondary outcomes
postoperative pulmonary complications
Time frame: Within 14 days after surgery; Within 30 days after surgery
specific indexes of ventilator-related lung injury
Time frame: Pre-surgery;Immediately after the extubation;Approximately 24 hours after surgery
oxygenation index
Time frame: Pre-surgery;20 minutes after the intubation;End of the operation;Approximately 10 minutes after the extubation;Approximately 40 minutes after the extubation;Approximately 70 minutes after the extubation;Approximately 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Yes. In June 2024, raw data was shared through ResMan（http://www.medresman.org.cn/login.aspx）
Related trials for Ventilator-associated Lung Injury
Recruiting
I-ASV in Cardiac Surgery
Ventilator Lung
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Not yet recruiting
Closed Versus Open Endotracheal Suctioning and Ventilator-Associated Pneumonia in Severe Traumatic Brain Injury
Ventilator-associated Pneumonia, Traumatic Brain Injury
Recruiting
Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
Bronchopulmonary Dysplasia, Pulmonary Hypertension
Recruiting
Inhaled Colistin to Prevent Ventilator-Associated Pneumonia in Patients With Acute Brain Injury
Ventilator-Associated Pneumonia (VAP), Inha'le'd
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. This study is not recruiting at the moment.
Zhongmeng Lai principal investigator
Fujian Medical University Union Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional ventilation strategies, Traditional lung-protective ventilation strategies and Innovative lung-protective ventilation strategies in people with Ventilator-associated Lung Injury and Atelectasis, run by Fujian Medical University Union Hospital at 3 sites 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingli Pan (+86 18065184976, panlin199104@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume ratio of new-onset atelectasis after surgery (time frame: Pre-surgery;Approximately 24 hours 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 1 Sep 2023.