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)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Test group (group T)
lung isolation was performed with visual double-lumen bronchial catheter, andcontinuous airway monitoring and intervention were performed
|
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
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of pulmonary complications
Time Frame: 3 days after operation
|
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
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
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Double lumen tube displacement
Time Frame: during the operation
|
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 Frame: during the operation
|
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
|
during the operation
|
|
Hypoxemia during operation
Time Frame: during the operation
|
Intraoperative SPO2<90% □ Yes □ No
|
during the operation
|
|
Intraoperative carbon dioxide accumulation
Time Frame: during the operation
|
PaCO2>45mmHg:□ No □ Yes: Duration|__|__| Minutes|__|__| Seconds;
|
during the operation
|
|
Incidence of tracheal intubation complications
Time Frame: three days after operation
|
Incidence of postoperative sore throat, hoarseness, etc.
|
three days after operation
|
|
Lung atrophy quality
Time Frame: during the operation
|
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
Time Frame: Postoperative
|
|
Postoperative
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2022YF060-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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