NCT06021249

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventilator-associated Lung Injury
• Atelectasis
• Postoperative Pulmonary Complications

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	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
PROCEDURE	Innovative lung-protective ventilation strategies	1. Tidal volume：6ml/kg PBW； 2. 5cmH2O PEEP； 3. positive pressure extubation； 4. postoperative breathing training
PROCEDURE	Lung-protective ventilation	1. Tidal volume：6ml/kg PBW； 2. 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	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.

Timeline

• Start date: 2021-09-28
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2023-09-01
• Last updated: 2023-09-01

Locations

3 sites across 1 country: China