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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pulmonary Complications
• Intervention / Treatment: Procedure: Continuous intra-airway monitoring and intervention during surgey

• Study Type: Interventional
• Enrollment (Anticipated): 376
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ye Chen, Master; Phone Number: 13906916355; Email: 1211020165@fjmu.edu.cn
• Study Contact Backup: Name: Xiaodong Xu, Master; Phone Number: 18650055080; Email: mamao_83@fjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group (group T); lung isolation was performed with visual double-lumen bronchial catheter, andcontinuous airway monitoring and intervention were performed	Procedure: Continuous 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
No Intervention: Control group (group C); lung isolation was performed with visual double-lumen bronchial catheter, and only intra-airway video was performed without monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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：□	during the operation
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	during the operation
Hypoxemia during operation	Intraoperative SPO2<90% □ Yes □ No; st time:|__|__| Minutes|__|___| Seconds;; nd time:|__|__| Minutes|__|___| Seconds;; rd time:|__|__| Minutes|__|___| Seconds;	during the operation
Intraoperative carbon dioxide accumulation	PaCO2>45mmHg：□ No □ Yes: Duration|__|__| Minutes|__|__| Seconds;	during the operation
Incidence of tracheal intubation complications	Incidence of postoperative sore throat, hoarseness, etc.	three days after operation
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	during the operation
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:NoneYes: □ 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)	Postoperative

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2022YF060-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No