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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Surgery; ERAS
• Intervention / Treatment: Procedure: Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol; Procedure: Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yunpeng Zhao; Phone Number: 18766188692; Email: zyp_baggio@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250033
      • Recruiting
      • The Second Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Completely Tubeless Group; 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.	Procedure: Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol; Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol
Active Comparator: Partially Tubeless Group; minimally invasive lung surgery under ERAS with partially tubeless protocol.	Procedure: Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol; Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Second Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: February 26, 2022
• First Submitted That Met QC Criteria: February 26, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: lung surgery; urinary catheter; enhanced recovery after surgery (ERAS); tubeless; no intubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: Completely Tubeless ZYP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No