search
Back to results

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

Primary Purpose

Ventilator-associated Lung Injury, Atelectasis, Postoperative Pulmonary Complications

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Traditional ventilation strategies
Traditional lung-protective ventilation strategies
Innovative lung-protective ventilation strategies
Lung-protective ventilation
negative pressure extubation
positive pressure extubation
postoperative breathing training
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator-associated Lung Injury focused on measuring perioperative strategies for lung-protective ventilation, elderly patients, atelectasis, postoperative pulmonary complications, lung injury

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting
  • The First Hospital of Putian
  • The First Affiliated Hospital of Nanchang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Sham Comparator

Experimental

Experimental

Experimental

Arm Label

Group of Control (Part I experiment)

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

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

Group of traditional & innovative ventilation (Part I experiment)

Group of Control (Part II experiment)

Group of positive pressure extubation (Part II experiment)

Group of breathing training (Part II experiment)

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

Arm Description

Traditional ventilation strategies

Traditional lung-protective ventilation strategies

Innovative lung-protective ventilation strategies

Traditional & innovative lung protection ventilation strategies

lung-protective ventilation; negative pressure extubation

lung-protective ventilation; positive pressure extubation

lung-protective ventilation; negative pressure extubation; postoperative breathing training

lung-protective ventilation; positive pressure extubation; postoperative breathing training

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
specific indexes of ventilator-related lung injury
Blood was drawn and centrifuged for serum ELISA to detect landmark indicators of ventilator-related lung injury
oxygenation index
Arterial blood samples are drawn for blood gas analysis

Full Information

First Posted
August 2, 2023
Last Updated
August 28, 2023
Sponsor
Fujian Medical University Union Hospital
Collaborators
The First Affiliated Hospital of Nanchang University, The First Hospital of Putian City, Putian, Fujian
search

1. Study Identification

Unique Protocol Identification Number
NCT06021249
Brief Title
Comparing Innovative and Traditional Ventilation Strategies on Atelectasis and Prognosis in Elderly Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union Hospital
Collaborators
The First Affiliated Hospital of Nanchang University, The First Hospital of Putian City, Putian, Fujian

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-associated Lung Injury, Atelectasis, Postoperative Pulmonary Complications
Keywords
perioperative strategies for lung-protective ventilation, elderly patients, atelectasis, postoperative pulmonary complications, lung injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group of Control (Part I experiment)
Arm Type
Sham Comparator
Arm Description
Traditional ventilation strategies
Arm Title
Group of traditional lung-protective ventilation (Part I experiment)
Arm Type
Experimental
Arm Description
Traditional lung-protective ventilation strategies
Arm Title
Group of innovative lung-protective ventilation (Part I experiment)
Arm Type
Experimental
Arm Description
Innovative lung-protective ventilation strategies
Arm Title
Group of traditional & innovative ventilation (Part I experiment)
Arm Type
Experimental
Arm Description
Traditional & innovative lung protection ventilation strategies
Arm Title
Group of Control (Part II experiment)
Arm Type
Sham Comparator
Arm Description
lung-protective ventilation; negative pressure extubation
Arm Title
Group of positive pressure extubation (Part II experiment)
Arm Type
Experimental
Arm Description
lung-protective ventilation; positive pressure extubation
Arm Title
Group of breathing training (Part II experiment)
Arm Type
Experimental
Arm Description
lung-protective ventilation; negative pressure extubation; postoperative breathing training
Arm Title
Group of positive pressure extubation & breathing training (Part II experiment)
Arm Type
Experimental
Arm Description
lung-protective ventilation; positive pressure extubation; postoperative breathing training
Intervention Type
Procedure
Intervention Name(s)
Traditional ventilation strategies
Intervention Description
Tidal volume:10ml/kg predicted body weight(PBW); 0 cm H2O positive end expiratory pressure(PEEP); negative pressure extubation
Intervention Type
Procedure
Intervention Name(s)
Traditional lung-protective ventilation strategies
Intervention Description
Tidal volume:6ml/kg PBW; 5cmH2O PEEP; Ventilator-controlled recruitment manoeuvre; CPAP; negative pressure extubation
Intervention Type
Procedure
Intervention Name(s)
Innovative lung-protective ventilation strategies
Intervention Description
Tidal volume:6ml/kg PBW; 5cmH2O PEEP; positive pressure extubation; postoperative breathing training
Intervention Type
Procedure
Intervention Name(s)
Lung-protective ventilation
Intervention Description
Tidal volume:6ml/kg PBW; 5cmH2O PEEP;
Intervention Type
Procedure
Intervention Name(s)
negative pressure extubation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
positive pressure extubation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
postoperative breathing training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Volume ratio of new-onset atelectasis after surgery
Description
After lung CT examination, the postoperative volume ratio of new atelectasis (new atelectasis volume/total lung volume) was calculated.
Time Frame
Pre-surgery;Approximately 24 hours after surgery
Secondary Outcome Measure Information:
Title
postoperative pulmonary complications
Description
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).
Time Frame
Within 14 days after surgery; Within 30 days after surgery
Title
specific indexes of ventilator-related lung injury
Description
Blood was drawn and centrifuged for serum ELISA to detect landmark indicators of ventilator-related lung injury
Time Frame
Pre-surgery;Immediately after the extubation;Approximately 24 hours after surgery
Title
oxygenation index
Description
Arterial blood samples are drawn for blood gas analysis
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lingli Pan
Phone
+86 18065184976
Email
panlin199104@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongmeng Lai
Phone
+86 13395000771
Email
angerer1980@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongmeng Lai
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingli Pan
Phone
+86 18065184976
Email
panlin199104@163.com
Facility Name
The First Hospital of Putian
City
Putian
State/Province
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huan Chen
Phone
+86 15080007150
Email
flyupinsky@163.com
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Min
Phone
+86 13970899291
Email
candymin66@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.medresman.org.cn/login.aspx

Learn more about this trial

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

We'll reach out to this number within 24 hrs