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

NCT06021249 | Unknown DMC

• 1 other identifier: 2021MZK04KY
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 3

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.

Conditions

Ventilator-associated Lung Injury; Atelectasis; Postoperative Pulmonary Complications

Keywords

perioperative strategies for lung-protective ventilation; elderly patients; atelectasis; postoperative pulmonary complications; lung injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• postoperative pulmonary complications

  Within 14 days after surgery; Within 30 days after surgery

• specific indexes of ventilator-related lung injury

  Pre-surgery;Immediately after the extubation;Approximately 24 hours after surgery

• 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

Study Arms (8)

Group of Control (Part I experiment)

SHAM COMPARATOR

Traditional ventilation strategies

Procedure: Traditional ventilation strategies

Group of traditional lung-protective ventilation (Part I experiment)

EXPERIMENTAL

Traditional lung-protective ventilation strategies

Procedure: Traditional lung-protective ventilation strategies

Group of innovative lung-protective ventilation (Part I experiment)

EXPERIMENTAL

Innovative lung-protective ventilation strategies

Procedure: Innovative lung-protective ventilation strategies

Group of traditional & innovative ventilation (Part I experiment)

EXPERIMENTAL

Traditional \& innovative lung protection ventilation strategies

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

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

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

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

Procedure: Lung-protective ventilation; Procedure: positive pressure extubation; Procedure: postoperative breathing training

Interventions

Traditional ventilation strategies PROCEDURE

1. Tidal volume：10ml/kg predicted body weight（PBW）； 2. 0 cm H2O positive end expiratory pressure（PEEP）； 3. negative pressure extubation

Group of Control (Part I experiment)

Traditional lung-protective ventilation strategies PROCEDURE

1. Tidal volume：6ml/kg PBW； 2. 5cmH2O PEEP； 3. Ventilator-controlled recruitment manoeuvre； 4. CPAP； 5. negative pressure extubation

Group of traditional & innovative ventilation (Part I experiment); Group of traditional lung-protective ventilation (Part I experiment)

Innovative lung-protective ventilation strategies PROCEDURE

1. Tidal volume：6ml/kg PBW； 2. 5cmH2O PEEP； 3. positive pressure extubation； 4. postoperative breathing training

Group of innovative lung-protective ventilation (Part I experiment); Group of traditional & innovative ventilation (Part I experiment)

Lung-protective ventilation PROCEDURE

1. Tidal volume：6ml/kg PBW； 2. 5cmH2O PEEP；

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 extubation PROCEDURE

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 Control (Part II experiment); Group of breathing training (Part II experiment)

positive pressure extubation PROCEDURE

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 positive pressure extubation & breathing training (Part II experiment); Group of positive pressure extubation (Part II experiment)

postoperative breathing training PROCEDURE

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 breathing training (Part II experiment); Group of positive pressure extubation & breathing training (Part II experiment)

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead
• The First Affiliated Hospital of Nanchang University: collaborator
• The First Hospital of Putian City, Putian, Fujian: collaborator

Study Sites (3)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

The First Hospital of Putian

Putian, Fujian, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis; Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Zhongmeng Lai

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingli Pan

CONTACT

+86 18065184976; panlin199104@163.com

Zhongmeng Lai

CONTACT

+86 13395000771; angerer1980@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: September 1, 2023
• Study Start: September 28, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: In June 2024, raw data was shared for 6 months.
• Access Criteria: Accessible to any researcher

Locations

CN (3)