Patients With Suspected Non-small Cell Lung Cancer (NSCLC) at Clinical Stage T1
Conditions
Brief summary
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.
Interventions
PROCEDURENon-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)
NIVATS 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.
Sponsors
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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); * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1; * Body Mass Index (BMI) \< 25 kg·m-²; * Normal cardiopulmonary function: predicted forced expiratory volume in the first second (FEV1%) \> 50%, resting blood gas analysis showing arterial oxygen partial pressure (PaO2) ≥ 75 mmHg, arterial carbon dioxide partial pressure (PaCO2) \< 45 mmHg; ejection fraction (EF) \> 50%, 6-minute walk distance (6MWD) ≥ 350 m; * No severe upper airway lesions, Mallampati classification I - II; * No contraindications related to paravertebral nerve block and intercostal nerve block; * Estimated surgical time ≤ 150 minutes; * Patients have no history of clinically significant cardiac or neurological problems.
Exclusion criteria
* 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; * Alteration of anesthesia or surgical plan; * Persistent cough or increased risk of high airway secretion reflux; * Mental disorders, inability to communicate, or refusal to sign the informed consent form; * Participation in other clinical trials within 1 month before this trial; * Those who are deemed unfit to participate in this trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average postoperative hospital stay | up to 3 months |
| Intraoperative opioid consumption | 1 day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung collapse score | 1 day | — |
| Intraoperative blood gas analysis (Q1h) | 1 day | — |
| Conversion to intubation rate | 1 day | — |
| Postoperative awakening time | 1 day | — |
| Time to first ambulation after surgery | up to 3 months | — |
| Ambulation rate within 4 hours after surgery | up to 3 months | — |
| Inflammatory markers (IL-6, peripheral neutrophil-to-lymphocyte ratio) | up to 3 months | — |
| Postoperative drainage volume | up to 3 months | — |
| Incidence of perioperative complications | up to 3 months | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| 15 item Quality of Recovery Rating Scale (QoR-15) | up to 1 year | — |
Contacts
CONTACTXiaolong Yan, Doctor of Medicine (M.D.)
Outcome results
None listed