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Effect of Continuous Intra-airway Monitoring Under Visible Double-lumen Bronchial Catheter on Postoperative Complications of Lung Surgery

Primary Purpose

Postoperative Pulmonary Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous intra-airway monitoring and intervention during surgey
Sponsored by
Fujian Medical University Union Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pulmonary Complications

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Age 18-80 years, BMI 18.5-28 kg/m2, male or female 2. Patients who are to undergo unilateral thoracoscopic resection of more than three lung segments or lobectomies 3. Patients who can be extubated with 35# and 37# double-lumen bronchial catheters after pre-anesthetic evaluation 4. Subjects voluntarily sign the informed consent form for this trial. 5. Patients or their caregivers are able to fill out the survey form and can correctly understand and cooperate with the postoperative rehabilitation instructions of the medical staff. 6. Patients have SPO2 ≥ 96% when inhaling air preoperatively Exclusion Criteria: 1. Patients with limited ability to cooperate with the study, such as the presence of cognitive dysfunction, mental illness, speech impairment or severe visual impairment or hearing impairment 2.ASA ≥IV 3. difficult airway, abnormal tracheal development, main airway stenosis, tumor, tracheoesophageal fistula 4. Complex sleeve pneumonectomy, unilateral total pneumonectomy, bilateral lung surgery 5. Preoperative anemia, Hb≤100g/L 6. Serum albumin ≤ 35g/L

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Test group (group T)

    Control group (group C)

    Arm Description

    lung isolation was performed with visual double-lumen bronchial catheter, andcontinuous airway monitoring and intervention were performed

    lung isolation was performed with visual double-lumen bronchial catheter, and only intra-airway video was performed without monitoring

    Outcomes

    Primary Outcome Measures

    Incidence of pulmonary complications
    Evaluation of the incidence of pulmonary complications three days after surgery by the Melbourne Assessment Scale Melbourne Group Scale(Minimum value 0 points ;Max 8 points Oral temperature > 38°C; White blood cell count > 11.2×10^12/L or use respiratory antibiotics (except prophylactic antibiotics); Pneumonia or pulmonary infection diagnosed by the treating doctor; Chest X-ray examination suggested atelectasis or consolidation; Purulent sputum (yellow/green) with characteristics different from those before operation; Sputum microbiological examination was positive; Oxygen saturation of finger pulse < 90% under suction condition; Readmission or ICU stay > 36h due to respiratory problems If 4 or more of the above 8 items are satisfied, the subject is considered to have developed pulmonary complications.

    Secondary Outcome Measures

    Double lumen tube displacement
    The number of times that fiberoptic bronchoscopy should be used to check or adjust the position during the operation, the rate of displacement, the degree of displacement, the number and time of operation suspension due to the adjustment of the position of double-lumen tube, etc Position adjustment assisted by fiberoptic(Check only unadjusted available at the back □ mark ×) □NO : 1stTime:|__|__|min|__|__|second;□ 2stTime:|__|__|min|__|__|second:□ 3stTime:|__|__|min|__|__|second:□ □YES: 1stTime:|__|__|min|__|__|second;□ 2stTime:|__|__|min|__|__|second:□ 3stTime:|__|__|min|__|__|second:□
    Intubation effectiveness
    Time taken for successful intubation and positioning (time from laryngoscope exposure to successful positioning of double lumen bronchial tube), success rate of first intubation and positioning, and probability of using fiber bronchoscopy for positioning Number of intubation times:|__| Times Time taken for successful intubation positioning:|__|__| Minutes|__|__| seconds Whether fiber bronchoscopy is used for positioning: □ No □ Yes
    Hypoxemia during operation
    Intraoperative SPO2<90% □ Yes □ No st time:|__|__| Minutes|__|___| Seconds; nd time:|__|__| Minutes|__|___| Seconds; rd time:|__|__| Minutes|__|___| Seconds;
    Intraoperative carbon dioxide accumulation
    PaCO2>45mmHg:□ No □ Yes: Duration|__|__| Minutes|__|__| Seconds;
    Incidence of tracheal intubation complications
    Incidence of postoperative sore throat, hoarseness, etc.
    Lung atrophy quality
    Lung atrophy quality during the operation(The condition is judged by the thoracic surgeon) 口Excellent visual field exposure, complete collapse of lung 口Medium The lungs are basically collapsed, but there's still residual air 口Poor Partial collapse or even non-collapse of the lung requires surgical intervention to expose the visual field
    Effectiveness of sputum suction
    Postoperative video review: The suction rate during intraoperative sputum suction: □ 80%-100%; □ 50-80%; □ 0-50%; After tracheal extubation, take photos to compare the secretion at the end of the bronchus: None Yes: □ Small amount (secretions adhering to the wall less than 2cm); □ Moderate amount (secretion adhering to the wall 2-4cm); □ Large amount (secretions sticking to the wall exceeding 4cm)

    Full Information

    First Posted
    January 31, 2023
    Last Updated
    April 24, 2023
    Sponsor
    Fujian Medical University Union Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05830474
    Brief Title
    Effect of Continuous Intra-airway Monitoring Under Visible Double-lumen Bronchial Catheter on Postoperative Complications of Lung Surgery
    Official Title
    Effect of Continuous Intra-airway Monitoring Under Visible Double-lumen Bronchial Catheter on Postoperative Complications of Lung Surgery (a Prospective, Single-center, Randomized, Controlled Clinical Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Medical University Union Hospital

    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
    The incidence of postoperative pulmonary complications (PPCs) after thoracic surgery is as high as 30-50% [1-6], which is the main cause of postoperative morbidity, death and prolonged hospital stay. Optimization of risk factors in PPCs procedures is the focus of current research. Double lumen bronchial tube (DLT) is a commonly used lung isolation method for adult patients. It has the advantages of good lung isolation effect, sufficient exposure of the surgical field and easy to attract secretions in the airway. However, there are still some deficiencies in clinical precise positioning, long-term continuous detection during operation, early detection of catheter displacement and other emergencies. Continuous intra-airway monitoring is the main advantage of visual double-lumen bronchial catheter. It can quickly and easily determine the position of the catheter and quickly adjust the displacement, and timely and effectively clean up the secretion in the airway, which is conducive to the analysis and treatment of intraoperative hypoxemia. Whether these potential advantages can reduce the incidence of PPCs deserves our in-depth discussion. The research group randomly divided the patients who were scheduled to undergo thoracoscopic radical resection of lung cancer in the Union Hospital affiliated to Fujian Medical University into the test group (lung isolation with visible double-lumen bronchial catheter, continuous intra-airway monitoring and intervention) and the control group: (Pulmonary isolation was performed with visual double-lumen bronchial catheter, and only intra-airway video was performed without monitoring. The effect of continuous intra-airway monitoring under visual double-lumen bronchial catheter on postoperative complications of lung surgery was evaluated by Melbourne evaluation scale.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pulmonary Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    376 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Test group (group T)
    Arm Type
    Experimental
    Arm Description
    lung isolation was performed with visual double-lumen bronchial catheter, andcontinuous airway monitoring and intervention were performed
    Arm Title
    Control group (group C)
    Arm Type
    No Intervention
    Arm Description
    lung isolation was performed with visual double-lumen bronchial catheter, and only intra-airway video was performed without monitoring
    Intervention Type
    Procedure
    Intervention Name(s)
    Continuous intra-airway monitoring and intervention during surgey
    Intervention Description
    Continuous monitoring was performed by visual double lumen bronchial catheter. Once sputum or blood gushing into the tracheal carina was found in the distal bronchus on the surgical side, the above secretions were sucked out with a sputum suction tube under video monitoring until the removal was complete
    Primary Outcome Measure Information:
    Title
    Incidence of pulmonary complications
    Description
    Evaluation of the incidence of pulmonary complications three days after surgery by the Melbourne Assessment Scale Melbourne Group Scale(Minimum value 0 points ;Max 8 points Oral temperature > 38°C; White blood cell count > 11.2×10^12/L or use respiratory antibiotics (except prophylactic antibiotics); Pneumonia or pulmonary infection diagnosed by the treating doctor; Chest X-ray examination suggested atelectasis or consolidation; Purulent sputum (yellow/green) with characteristics different from those before operation; Sputum microbiological examination was positive; Oxygen saturation of finger pulse < 90% under suction condition; Readmission or ICU stay > 36h due to respiratory problems If 4 or more of the above 8 items are satisfied, the subject is considered to have developed pulmonary complications.
    Time Frame
    3 days after operation
    Secondary Outcome Measure Information:
    Title
    Double lumen tube displacement
    Description
    The number of times that fiberoptic bronchoscopy should be used to check or adjust the position during the operation, the rate of displacement, the degree of displacement, the number and time of operation suspension due to the adjustment of the position of double-lumen tube, etc Position adjustment assisted by fiberoptic(Check only unadjusted available at the back □ mark ×) □NO : 1stTime:|__|__|min|__|__|second;□ 2stTime:|__|__|min|__|__|second:□ 3stTime:|__|__|min|__|__|second:□ □YES: 1stTime:|__|__|min|__|__|second;□ 2stTime:|__|__|min|__|__|second:□ 3stTime:|__|__|min|__|__|second:□
    Time Frame
    during the operation
    Title
    Intubation effectiveness
    Description
    Time taken for successful intubation and positioning (time from laryngoscope exposure to successful positioning of double lumen bronchial tube), success rate of first intubation and positioning, and probability of using fiber bronchoscopy for positioning Number of intubation times:|__| Times Time taken for successful intubation positioning:|__|__| Minutes|__|__| seconds Whether fiber bronchoscopy is used for positioning: □ No □ Yes
    Time Frame
    during the operation
    Title
    Hypoxemia during operation
    Description
    Intraoperative SPO2<90% □ Yes □ No st time:|__|__| Minutes|__|___| Seconds; nd time:|__|__| Minutes|__|___| Seconds; rd time:|__|__| Minutes|__|___| Seconds;
    Time Frame
    during the operation
    Title
    Intraoperative carbon dioxide accumulation
    Description
    PaCO2>45mmHg:□ No □ Yes: Duration|__|__| Minutes|__|__| Seconds;
    Time Frame
    during the operation
    Title
    Incidence of tracheal intubation complications
    Description
    Incidence of postoperative sore throat, hoarseness, etc.
    Time Frame
    three days after operation
    Title
    Lung atrophy quality
    Description
    Lung atrophy quality during the operation(The condition is judged by the thoracic surgeon) 口Excellent visual field exposure, complete collapse of lung 口Medium The lungs are basically collapsed, but there's still residual air 口Poor Partial collapse or even non-collapse of the lung requires surgical intervention to expose the visual field
    Time Frame
    during the operation
    Title
    Effectiveness of sputum suction
    Description
    Postoperative video review: The suction rate during intraoperative sputum suction: □ 80%-100%; □ 50-80%; □ 0-50%; After tracheal extubation, take photos to compare the secretion at the end of the bronchus: None Yes: □ Small amount (secretions adhering to the wall less than 2cm); □ Moderate amount (secretion adhering to the wall 2-4cm); □ Large amount (secretions sticking to the wall exceeding 4cm)
    Time Frame
    Postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Age 18-80 years, BMI 18.5-28 kg/m2, male or female 2. Patients who are to undergo unilateral thoracoscopic resection of more than three lung segments or lobectomies 3. Patients who can be extubated with 35# and 37# double-lumen bronchial catheters after pre-anesthetic evaluation 4. Subjects voluntarily sign the informed consent form for this trial. 5. Patients or their caregivers are able to fill out the survey form and can correctly understand and cooperate with the postoperative rehabilitation instructions of the medical staff. 6. Patients have SPO2 ≥ 96% when inhaling air preoperatively Exclusion Criteria: 1. Patients with limited ability to cooperate with the study, such as the presence of cognitive dysfunction, mental illness, speech impairment or severe visual impairment or hearing impairment 2.ASA ≥IV 3. difficult airway, abnormal tracheal development, main airway stenosis, tumor, tracheoesophageal fistula 4. Complex sleeve pneumonectomy, unilateral total pneumonectomy, bilateral lung surgery 5. Preoperative anemia, Hb≤100g/L 6. Serum albumin ≤ 35g/L
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ye Chen, Master
    Phone
    13906916355
    Email
    1211020165@fjmu.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaodong Xu, Master
    Phone
    18650055080
    Email
    mamao_83@fjmu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effect of Continuous Intra-airway Monitoring Under Visible Double-lumen Bronchial Catheter on Postoperative Complications of Lung Surgery

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