Comparing Innovative and Traditional Ventilation Strategies on Atelectasis and Prognosis in Elderly Patients
NCT ID: NCT06021249
Last Updated: 2023-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
304 participants
INTERVENTIONAL
2021-09-28
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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Group of Control (Part I experiment)
Traditional ventilation strategies
Traditional ventilation strategies
1. Tidal volume：10ml/kg predicted body weight（PBW）；
2. 0 cm H2O positive end expiratory pressure（PEEP）；
3. negative pressure extubation
Group of traditional lung-protective ventilation (Part I experiment)
Traditional lung-protective ventilation strategies
Traditional lung-protective ventilation strategies
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
3. Ventilator-controlled recruitment manoeuvre；
4. CPAP；
5. negative pressure extubation
Group of innovative lung-protective ventilation (Part I experiment)
Innovative lung-protective ventilation strategies
Innovative lung-protective ventilation strategies
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
3. positive pressure extubation；
4. postoperative breathing training
Group of traditional & innovative ventilation (Part I experiment)
Traditional \& innovative lung protection ventilation strategies
Traditional lung-protective ventilation strategies
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
3. Ventilator-controlled recruitment manoeuvre；
4. CPAP；
5. negative pressure extubation
Innovative lung-protective ventilation strategies
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
3. positive pressure extubation；
4. postoperative breathing training
Group of Control (Part II experiment)
1. lung-protective ventilation；
2. negative pressure extubation
Lung-protective ventilation
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
negative pressure extubation
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.
Group of positive pressure extubation (Part II experiment)
1. lung-protective ventilation；
2. positive pressure extubation
Lung-protective ventilation
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
positive pressure extubation
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.
Group of breathing training (Part II experiment)
1. lung-protective ventilation；
2. negative pressure extubation；
3. postoperative breathing training
Lung-protective ventilation
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
negative pressure extubation
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.
postoperative breathing training
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.
Group of positive pressure extubation & breathing training (Part II experiment)
1. lung-protective ventilation；
2. positive pressure extubation；
3. postoperative breathing training
Lung-protective ventilation
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
positive pressure extubation
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 training
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.
Interventions
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Traditional ventilation strategies
1. Tidal volume：10ml/kg predicted body weight（PBW）；
2. 0 cm H2O positive end expiratory pressure（PEEP）；
3. negative pressure extubation
Traditional lung-protective ventilation strategies
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
3. Ventilator-controlled recruitment manoeuvre；
4. CPAP；
5. negative pressure extubation
Innovative lung-protective ventilation strategies
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
3. positive pressure extubation；
4. postoperative breathing training
Lung-protective ventilation
1. Tidal volume：6ml/kg PBW；
2. 5cmH2O PEEP；
negative pressure extubation
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 extubation
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 training
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.
Eligibility Criteria
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Inclusion Criteria
2. Body mass index（BMI） \<30；
3. American society of anesthesiologists physical status classification system（ASA）:I-III；
4. When the patient inhales air before surgery, SPO2≥94%；
5. The duration of the operation is 2-7 hours, and the pneumoperitoneal pressure is 10-14mmHg.
Exclusion Criteria
2. Patients with acute respiratory infections within one month before surgery
3. Patients who have undergone cardiopulmonary surgery
4. Receiving invasive mechanical ventilation for more than 30min within 30 days before surgery
5. Patients with peak airway pressure \> 35 cm H2O during intraoperative mechanical ventilation
6. Patients with severe organic lesions of the heart such as obvious heart failure and coronary heart disease
7. Patients with preoperative anemia (Hb\<10g/L)
8. Patients with hypoproteinemia before surgery (albumin \< 35 g/L)
9. Patients with tracheostomy and severe difficult airway
10. Patients with sleep apnea syndrome
11. Patients with intraoperative heavy bleeding (50% of the circulating blood volume is lost ≥ 3 hours)
12. Patients with mental illness, impaired consciousness and communication disorders
13. Patients who refuse to participate in this trial
60 Years
100 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Nanchang University
OTHER
The First Hospital of Putian City, Putian, Fujian
OTHER_GOV
Fujian Medical University Union Hospital
OTHER
Responsible Party
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Principal Investigators
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Zhongmeng Lai
Role: PRINCIPAL_INVESTIGATOR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Hospital of Putian
Putian, Fujian, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021MZK04KY
Identifier Type: -
Identifier Source: org_study_id
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