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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lingli Pan; Phone Number: +86 18065184976; Email: panlin199104@163.com
• Study Contact Backup: Name: Zhongmeng Lai; Phone Number: +86 13395000771; Email: angerer1980@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Lingli Pan; Phone Number: +86 18065184976; Email: panlin199104@163.com
    • Putian, Fujian, China
      • Not yet recruiting
      • The First Hospital of Putian
      • Contact: Huan Chen; Phone Number: +86 15080007150; Email: flyupinsky@163.com
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Jia Min; Phone Number: +86 13970899291; Email: candymin66@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group of Control (Part I experiment); Traditional ventilation strategies	Procedure: Traditional ventilation strategies; Tidal volume：10ml/kg predicted body weight（PBW）；; 0 cm H2O positive end expiratory pressure（PEEP）；; negative pressure extubation
Experimental: Group of traditional lung-protective ventilation (Part I experiment); Traditional lung-protective ventilation strategies	Procedure: Traditional lung-protective ventilation strategies; Tidal volume：6ml/kg PBW；; 5cmH2O PEEP；; Ventilator-controlled recruitment manoeuvre；; CPAP；; negative pressure extubation
Experimental: Group of innovative lung-protective ventilation (Part I experiment); Innovative lung-protective ventilation strategies	Procedure: Innovative lung-protective ventilation strategies; Tidal volume：6ml/kg PBW；; 5cmH2O PEEP；; positive pressure extubation；; postoperative breathing training
Experimental: Group of traditional & innovative ventilation (Part I experiment); Traditional & innovative lung protection ventilation strategies	Procedure: Traditional lung-protective ventilation strategies; Tidal volume：6ml/kg PBW；; 5cmH2O PEEP；; Ventilator-controlled recruitment manoeuvre；; CPAP；; negative pressure extubation; Procedure: Innovative lung-protective ventilation strategies; Tidal volume：6ml/kg PBW；; 5cmH2O PEEP；; positive pressure extubation；; postoperative breathing training
Sham Comparator: Group of Control (Part II experiment); lung-protective ventilation；; negative pressure extubation	Procedure: Lung-protective ventilation; Tidal volume：6ml/kg PBW；; 5cmH2O PEEP； Procedure: 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.
Experimental: Group of positive pressure extubation (Part II experiment); lung-protective ventilation；; positive pressure extubation	Procedure: Lung-protective ventilation; Tidal volume：6ml/kg PBW；; 5cmH2O PEEP； Procedure: 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.
Experimental: Group of breathing training (Part II experiment); lung-protective ventilation；; negative pressure extubation；; postoperative breathing training	Procedure: Lung-protective ventilation; Tidal volume：6ml/kg PBW；; 5cmH2O PEEP； Procedure: 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.; Procedure: 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.
Experimental: Group of positive pressure extubation & breathing training (Part II experiment); lung-protective ventilation；; positive pressure extubation；; postoperative breathing training	Procedure: Lung-protective ventilation; Tidal volume：6ml/kg PBW；; 5cmH2O PEEP； Procedure: 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-surgery;Approximately 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	Pre-surgery;Immediately after the extubation;Approximately 24 hours after surgery
oxygenation index	Arterial blood samples are drawn for blood gas analysis	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

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; The First Hospital of Putian City, Putian, Fujian
• Investigators: Principal Investigator: Zhongmeng Lai, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: atelectasis; lung injury; elderly patients; postoperative pulmonary complications; perioperative strategies for lung-protective ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Pulmonary Atelectasis; Lung Injury
• Other Study ID Numbers: 2021MZK04KY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In June 2024, raw data was shared through ResMan（http://www.medresman.org.cn/login.aspx）
• IPD Sharing Time Frame: In June 2024, raw data was shared for 6 months.
• IPD Sharing Access Criteria: Accessible to any researcher
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No