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

Atelectasis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021249
• Other study ID #: 2021MZK04KY
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Fujian Medical University Union Hospital
• Contact: Lingli Pan
• Phone: +86 18065184976
• Email: panlin199104[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 304
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Traditional ventilation strategies
Tidal volume:10ml/kg predicted body weight(PBW); 0 cm H2O positive end expiratory pressure(PEEP); negative pressure extubation
• Traditional lung-protective ventilation strategies
Tidal volume:6ml/kg PBW; 5cmH2O PEEP; Ventilator-controlled recruitment manoeuvre; CPAP; negative pressure extubation
• Innovative lung-protective ventilation strategies
Tidal volume:6ml/kg PBW; 5cmH2O PEEP; positive pressure extubation; postoperative breathing training
• Lung-protective ventilation
Tidal volume:6ml/kg PBW; 5cmH2O PEEP;
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	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

Sponsors (3)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital	The First Affiliated Hospital of Nanchang University, The First Hospital of Putian City, Putian, Fujian

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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