Anesthesia Comparison in Early-stage Small NSCLC: A Multicenter RCT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 75
SponsorTang-Du Hospital
About this trial
This study is a prospective, randomized, controlled study, which intends to enroll patients with suspected early-stage NSCLC (non-small cell lung cancer) with a diameter of ≤ 3 cm as research subjects. The study is conducted in accordance with the Declaration of Helsinki. It has been approved by the Ethics Committee of the Second Affiliated Hospital of Air Force Medical University, and patients or their family members have signed the informed consent form. Patients undergoing VATS (video-assisted thoracic surgery) are enrolled in the Department of Thoracic Surgery of the Second Affiliated Hospital of Air Force Medical University. The patients are randomly divided into two groups: the NIVATS (non-intubated video-assisted thoracic surgery) group and the OLV (one-lung ventilation) group. By observing various perioperative indicators of the patients, the short-term efficacy of the two techniques in patients with early-stage NSCLC is compared, so as to evaluate the safety and effectiveness of the NIVATS surgical treatment method.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≤ 75 years;
Gender is not limited;
Patients with suspected T1 stage non-small cell lung cancer (NSCLC) in preoperative clinical staging, with thin-slice CT showing that the maximum tumor diameter is ≤ 3.0 cm, single or multiple nodules, and the nodules requiring surgical resection are located in the same ipsilateral lung lobe, with the number of nodules resected simultaneously ≤ 3;
American Society of Anesthesiologists (ASA) classification ≤ Grade III (preferably Grade I - II is recommended);
Disqualifiers
A history of ipsilateral lung surgery;
Interstitial pneumonia, pulmonary fibrosis, severe emphysema, severe chronic obstructive pulmonary disease, acute phase of pulmonary infection, or uncontrolled asthma;
Sleep apnea syndrome with anticipated airway difficulty or difficulty in airway management;
Preoperative complications including coagulation dysfunction, hypoxemia, hypercapnia, or hepatic/renal insufficiency;
Trial design
Design model
Parallel
Treatments tested in this trial
Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)
Procedure/SurgeryNIVATS is a special method developed in the past two decades. It means that patients do not undergo tracheal intubation under general anesthesia during the entire surgical process, retaining their spontaneous breathing, but supraglottic airway devices (such as laryngeal masks, high-flow nasal catheters, mask ventilation) can be used to support their breathing. The purpose of this technology is to minimize the impact of general anesthesia, tracheal intubation, mechanical ventilation, etc. on patients.
Treatment groups
410 Participants
are divided into 2 treatment groupsGroup A: group AExperimental treatment 1 intervention
Group B: group BPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average postoperative hospital stay
Time frame
up to 3 months2
Intraoperative opioid consumption
Time frame
1 daySecondary outcomes
1
Lung collapse score
Time frame
1 day2
Intraoperative blood gas analysis (Q1h)
Time frame
1 day3
Conversion to intubation rate
Time frame
1 day4
Postoperative awakening time
Time frame
1 dayOther outcomes
1
The impact of nursing education on discharge time and time to first ambulation after surgery
Time frame
up to 3 months2
Comparison of the effects of thoracic paravertebral nerve block and intrathoracic intercostal nerve block
Time frame
up to 3 months3
1-, 3-, and 5-year disease-free survival (DFS)
Time frame
up to 5 years4
1-, 3-, 5-, and 10-year overall survival (OS)
Time frame
up to 10 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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