Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol Compared With That With Partially Tubeless Protocol

The Second Hospital of Shandong University

Status: Enrolling

Conditions: ERAS; Lung Diseases; Surgery

Treatments: Procedure: Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol; Procedure: Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05269784

Completely Tubeless ZYP

Details and patient eligibility

About

Previous studies have shown the feasibility of ERAS on minimally invasive lung surgery, but it is unknown whether completely tubeless protocol is safe and better. This study aimed to determine whether completely tubeless protocol is feasible and beneficial for minimally invasive lung surgery, compared with partially tubeless protocol.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

(I) Wedge resection or sub-lobar resection or lobectomy is considered as the primary surgical strategy. The operation ideally should not exceed 2 hours; (II) No absolute age limit; (III) Patients with Eastern Cooperative Oncology Group (ECOG) physical performance score of ≤2 points; (IV) P a t i e n t s w i t h a n A m e r i c a n S o c i e t y o f Anesthesiologists Standard (ASA) grade of ≤ III; (V) Body mass index (BMI) <30 kg/m2; (VI) Patients with no clinically significant cardiac history, such as ischaemic heart disease, valvular heart disease, rhythm disturbances such as frequent atrial fibrillation or premature ventricular contractions (PVCs). Patients with significant cardiac history should be optimized according the relevant guidelines before surgery is considered; (VII) Normal cardiopulmonary function [predicted forced expiratory volume in the first second (FEV1%) >50% and ejection fraction (EF) >50% of predicted value]. Resting blood gas analysis showing arterial partial pressure of oxygen (PaO2)≥75 mmHg and arterial partial pressure of carbon dioxide (PaCO2) <45 mmHg; (VIII) Normal renal function and no history of urological problems.

Exclusion criteria

(I) Patient-related factors: (i) Patients who refuse surgery and/or the anesthesia protocols; (ii) Coagulopathy, hypoxemia (PaO2 <60 mmHg), hypercapnia [arterial carbon dioxide tension (PaCO2) >50 mmHg], or elevated risk of regurgitation (<6 hours of fasting) preoperatively or combined with gastroesophageal reflux disease; neurological disorders; (iii) Severe acute pulmonary infection or tuberculosis; (iv) Relative contraindications: upper airway secretions or persistent cough, spinal deformity, or brain edema (if thoracic epidural anesthesia is to be used); (v) History of ipsilateral surgery and other conditions which can result in extensive pleural adhesion; (vi) Phrenic nerve paralysis on the non-operated side should be viewed as a contraindication to VATS; (vii) History of urological conditions increasing the need for urinary catheterization; (viii) Significant cardiac history. (II) Anesthesia-related factors: (i) Allergy to local anesthesia; (ii) Any contraindication to the regional anesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

Completely Tubeless Group

Experimental group

Description:

minimally invasive lung surgery under ERAS with completely tubeless protocol: no intubation, no urinary catheter, move the chest drainage as fast as possible according the ERAS guideline on the premise of safety.

Treatment:

Procedure: Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol

Partially Tubeless Group

Active Comparator group

Description:

minimally invasive lung surgery under ERAS with partially tubeless protocol.

Treatment:

Procedure: Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol