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

NCT05830474 | Unknown DMC

• 1 other identifier: 2022YF060-01
• Study Type: interventional
• Target: 376
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pulmonary Complications

Outcome Measures

Primary Outcomes (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.

  3 days after operation

Secondary Outcomes (7)

• Double lumen tube displacement

  during the operation

• Intubation effectiveness

  during the operation

• Hypoxemia during operation

  during the operation

• Intraoperative carbon dioxide accumulation

  during the operation

• Incidence of tracheal intubation complications

  three days after operation

Study Arms (2)

Test group (group T)

EXPERIMENTAL

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

Control group (group C)

NO INTERVENTION

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

Interventions

Continuous intra-airway monitoring and intervention during surgey PROCEDURE

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

Test group (group T)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-80 years, BMI 18.5-28 kg/m2, male or female
• \. Patients who are to undergo unilateral thoracoscopic resection of more than three lung segments or lobectomies
• \. Patients who can be extubated with 35# and 37# double-lumen bronchial catheters after pre-anesthetic evaluation
• \. Subjects voluntarily sign the informed consent form for this trial.
• \. 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.
• \. Patients have SPO2 ≥ 96% when inhaling air preoperatively

You may not qualify if:

• \. 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
• ASA ≥IV
• \. difficult airway, abnormal tracheal development, main airway stenosis, tumor, tracheoesophageal fistula
• \. Complex sleeve pneumonectomy, unilateral total pneumonectomy, bilateral lung surgery
• \. Preoperative anemia, Hb≤100g/L
• \. Serum albumin ≤ 35g/L

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Central Study Contacts

Ye Chen, Master

CONTACT

13906916355; 1211020165@fjmu.edu.cn

Xiaodong Xu, Master

CONTACT

18650055080; mamao_83@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: April 26, 2023
• Study Start: May 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04