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Postoperative Pulmonary ComplicationsNCT05830474

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

A study testing Continuous intra-airway monitoring and intervention during surgey in people with Postoperative Pulmonary Complications, run by Fujian Medical University Union Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Postoperative Pulmonary Complications
What is being tested?
Continuous intra-airway monitoring and intervention during surgey
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
No sites listed yet
Study dates
15 May 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Ye Chen, Master contact

13906916355

1211020165@fjmu.edu.cn

Xiaodong Xu, Master contact

18650055080

mamao_83@fjmu.edu.cn

About this study

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)

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.

Being tested
Continuous intra-airway monitoring and intervention during surgey

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous intra-airway monitoring and intervention during surgeyProcedure or surgery

    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

Study groups in NCT05830474
Study groupRoleWhat they receive
Test group (group T)Experimentallung isolation was performed with visual double-lumen bronchial catheter, andcontinuous airway monitoring and intervention were performed
Receives: Procedure: Continuous intra-airway monitoring and intervention during surgey
Control group (group C)No interventionlung isolation was performed with visual double-lumen bronchial catheter, and only intra-airway video was performed without monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    1. Oral temperature > 38°C;
    2. White blood cell count > 11.2×10^12/L or use respiratory antibiotics (except prophylactic antibiotics);
    3. Pneumonia or pulmonary infection diagnosed by the treating doctor;
    4. Chest X-ray examination suggested atelectasis or consolidation;
    5. Purulent sputum (yellow/green) with characteristics different from those before operation;
    6. Sputum microbiological examination was positive;
    7. Oxygen saturation of finger pulse < 90% under suction condition;
    8. 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.

    Measured: 3 days after operation

Secondary outcomes (7)

  1. 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：□

    Measured: during the operation

  2. 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

    1. Number of intubation times:|__| Times
    2. Time taken for successful intubation positioning:|__|__| Minutes|__|__| seconds
    3. Whether fiber bronchoscopy is used for positioning: □ No □ Yes

    Measured: during the operation

  3. Hypoxemia during operation

    Intraoperative SPO2<90%

    □ Yes □ No

    1. st time:|__|__| Minutes|__|___| Seconds;
    2. nd time:|__|__| Minutes|__|___| Seconds;
    3. rd time:|__|__| Minutes|__|___| Seconds;

    Measured: during the operation

  4. Intraoperative carbon dioxide accumulation

    PaCO2>45mmHg：□ No □ Yes: Duration|__|__| Minutes|__|__| Seconds;

    Measured: during the operation

  5. Incidence of tracheal intubation complications

    Incidence of postoperative sore throat, hoarseness, etc.

    Measured: three days after operation

  6. 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

    Measured: during the operation

  7. Effectiveness of sputum suction

    1. Postoperative video review: The suction rate during intraoperative sputum suction: □ 80%-100%； □ 50-80%; □ 0-50%;
    2. 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)

    Measured: Postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2023
  2. Study start15 May 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
376 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05830474
Sponsor's protocol ID
2022YF060-01
Status last verified
Apr 2023
First submitted
31 Jan 2023
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Continuous intra-airway monitoring and intervention during surgey in people with Postoperative Pulmonary Complications, run by Fujian Medical University Union Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ye Chen, Master (13906916355, 1211020165@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of pulmonary complications (time frame: 3 days after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05830474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.

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