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

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05830474
Enrollment
376
Registered
2023-04-26
Start date
2023-05-15
Completion date
2023-12-31
Last updated
2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pulmonary Complications

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.

Interventions

PROCEDUREContinuous intra-airway monitoring and intervention during surgey

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

Sponsors

Fujian Medical University Union Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of pulmonary complications3 days after operationEvaluation 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.

Secondary

MeasureTime frameDescription
Intubation effectivenessduring the operationTime 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
Hypoxemia during operationduring the operationIntraoperative SPO2\<90% □ Yes □ No 1. st time:\|\_\_\|\_\_\| Minutes\|\_\_\|\_\_\_\| Seconds; 2. nd time:\|\_\_\|\_\_\| Minutes\|\_\_\|\_\_\_\| Seconds; 3. rd time:\|\_\_\|\_\_\| Minutes\|\_\_\|\_\_\_\| Seconds;
Intraoperative carbon dioxide accumulationduring the operationPaCO2\>45mmHg:□ No □ Yes: Duration\|\_\_\|\_\_\| Minutes\|\_\_\|\_\_\| Seconds;
Double lumen tube displacementduring the operationThe 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:□
Lung atrophy qualityduring the operationLung 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 suctionPostoperative1. 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)
Incidence of tracheal intubation complicationsthree days after operationIncidence of postoperative sore throat, hoarseness, etc.

Contacts

Primary ContactYe Chen, Master
1211020165@fjmu.edu.cn13906916355
Backup ContactXiaodong Xu, Master
mamao_83@fjmu.edu.cn18650055080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026