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

Not Applicable

Recruiting

• Conditions: Surgery; Lung Diseases; ERAS
• Interventions: Procedure: Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol; Procedure: Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol

• Registration Number: NCT05269784
• Lead Sponsor: The Second Hospital of Shandong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-26
• Study First Submitted QC: 2022-02-26
• Study First Posted: 2022-03-08
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-16
• Primary Completion: 2022-12-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Completely Tubeless Group	Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol	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.
Partially Tubeless Group	Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol	minimally invasive lung surgery under ERAS with partially tubeless protocol.

Primary Outcome Measures

Name	Time	Method
Pain degree	within 7 days after surgery	On a scale of 1 to 10
urinary irritation and urinary tract infection	within a week after surgery	incidence rate
0-degree discomfort	within 3 days after surgery	proportion
operation time	within 150 minutes	minutes
volume of drainage	within 7 days after surgery	ml
drainage duration time	within 7 days after surgery	days
duration of postoperative hospital stay	within 7 days after surgery	days
pneumonia	within 7 days after surgery	incidence rate
bleeding volume	during surgery	ml ml

Trial Locations

Locations (1)

The Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China