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

Sponsor

Fujian Medical University Union Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06021249

Collaborator

The First Affiliated Hospital of Nanchang University (Other), The First Hospital of Putian City, Putian, Fujian (Other)

304

Enrollment

Locations

Arms

32.1

Anticipated Duration (Months)

101.3

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilator-associated Lung Injury Atelectasis Postoperative Pulmonary Complications	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	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

304 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Sep 28, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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: 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).
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Contacts and Locations

Locations

	Site	City	State	Country
1	Fujian Medical University Union Hospital	Fuzhou	Fujian	China
2	The First Hospital of Putian	Putian	Fujian	China
3	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China