Comparing Innovative and Traditional Ventilation Strategies on Atelectasis and Prognosis in Elderly Patients

Not Applicable

Recruiting

• Conditions: Atelectasis; Ventilator-associated Lung Injury; Postoperative Pulmonary Complications
• Interventions: Procedure: Traditional ventilation strategies; Procedure: Traditional lung-protective ventilation strategies; Procedure: Lung-protective ventilation; Procedure: negative pressure extubation; Procedure: Innovative lung-protective ventilation strategies; Procedure: positive pressure extubation; Procedure: postoperative breathing training

• Registration Number: NCT06021249
• Lead Sponsor: Fujian Medical University Union Hospital

Brief 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 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 Timeline

• Study Start: 2021-09-28
• Status Verified: 2023-08
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-28
• Last Update Submitted: 2023-08-28
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

1. Elderly patients aged ≥ 60 years old who undergo laparoscopic abdominal surgery；
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

1. Patients with acute respiratory distress syndrome or pulmonary hypertension (pulmonary systolic blood pressure ≥ 40mmHg) or bronchiectasis or lung malignant tumors
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group of Control (Part I experiment)	Traditional ventilation strategies	Traditional ventilation strategies
Group of traditional lung-protective ventilation (Part I experiment)	Traditional lung-protective ventilation strategies	Traditional lung-protective ventilation strategies
Group of Control (Part II experiment)	negative pressure extubation	1. lung-protective ventilation； 2. negative pressure extubation
Group of positive pressure extubation (Part II experiment)	Lung-protective ventilation	1. lung-protective ventilation； 2. positive pressure extubation
Group of breathing training (Part II experiment)	Lung-protective ventilation	1. lung-protective ventilation； 2. negative pressure extubation； 3. postoperative breathing training
Group of traditional & innovative ventilation (Part I experiment)	Innovative lung-protective ventilation strategies	Traditional \& innovative lung protection ventilation strategies
Group of Control (Part II experiment)	Lung-protective ventilation	1. lung-protective ventilation； 2. negative pressure extubation
Group of innovative lung-protective ventilation (Part I experiment)	Innovative lung-protective ventilation strategies	Innovative lung-protective ventilation strategies
Group of traditional & innovative ventilation (Part I experiment)	Traditional lung-protective ventilation strategies	Traditional \& innovative lung protection ventilation strategies
Group of positive pressure extubation & breathing training (Part II experiment)	positive pressure extubation	1. lung-protective ventilation； 2. positive pressure extubation； 3. postoperative breathing training
Group of positive pressure extubation (Part II experiment)	positive pressure extubation	1. lung-protective ventilation； 2. positive pressure extubation
Group of breathing training (Part II experiment)	negative pressure extubation	1. lung-protective ventilation； 2. negative pressure extubation； 3. postoperative breathing training
Group of breathing training (Part II experiment)	postoperative breathing training	1. lung-protective ventilation； 2. negative pressure extubation； 3. postoperative breathing training
Group of positive pressure extubation & breathing training (Part II experiment)	Lung-protective ventilation	1. lung-protective ventilation； 2. positive pressure extubation； 3. postoperative breathing training
Group of positive pressure extubation & breathing training (Part II experiment)	postoperative breathing training	1. lung-protective ventilation； 2. positive pressure extubation； 3. postoperative breathing training

Primary Outcome Measures

Name	Time	Method
Volume ratio of new-onset atelectasis after surgery	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.

Secondary Outcome Measures

Name	Time	Method
postoperative pulmonary complications	Within 14 days after surgery; Within 30 days after surgery	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: 1. fever (\>38°C) with no other recognised cause,; 2. leucopaenia (white cell count \<4\*10\^9/ litre) or leucocytosis(white cell count \>12\*10\^9 /litre),; 3. for adults \>70 years old, altered mental status with no other recognised cause; AND at least two of the following: 1. new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements,; 2. new onset or worsening cough, or dyspnoea, or tachypnoea,; 3. rales or bronchial breath sounds,; 4. worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).
specific indexes of ventilator-related lung injury	Pre-surgery;Immediately after the extubation;Approximately 24 hours after surgery	Blood was drawn and centrifuged for serum ELISA to detect landmark indicators of ventilator-related lung injury
oxygenation index	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	Arterial blood samples are drawn for blood gas analysis

Trial Locations

Locations (3)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

The First Hospital of Putian; 🇨🇳 Putian, Fujian, China