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

Last updated: November 14, 2022
Sponsor: The Second Hospital of Shandong University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Treatment

N/A

Clinical Study ID

NCT05269784
Completely Tubeless ZYP
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

(I) Wedge resection or sub-lobar resection or lobectomy is considered as the primarysurgical strategy. The operation ideally should not exceed 2 hours; (II) No absolute agelimit; (III) Patients with Eastern Cooperative Oncology Group (ECOG) physical performancescore 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 fAnesthesiologists 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 orpremature ventricular contractions (PVCs). Patients with significant cardiac history shouldbe optimized according the relevant guidelines before surgery is considered; (VII) Normalcardiopulmonary function [predicted forced expiratory volume in the first second (FEV1%) >50% and ejection fraction (EF) >50% of predicted value]. Resting blood gas analysisshowing arterial partial pressure of oxygen (PaO2)≥75 mmHg and arterial partial pressure ofcarbon dioxide (PaCO2) <45 mmHg; (VIII) Normal renal function and no history of urologicalproblems.

Exclusion

Exclusion Criteria:

(I) Patient-related factors: (i) Patients who refuse surgery and/or the anesthesiaprotocols; (ii) Coagulopathy, hypoxemia (PaO2 <60 mmHg), hypercapnia [arterial carbondioxide 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 thoracicepidural anesthesia is to be used); (v) History of ipsilateral surgery and other conditionswhich can result in extensive pleural adhesion; (vi) Phrenic nerve paralysis on thenon-operated side should be viewed as a contraindication to VATS; (vii) History ofurological conditions increasing the need for urinary catheterization; (viii) Significantcardiac history. (II) Anesthesia-related factors: (i) Allergy to local anesthesia; (ii) Anycontraindication to the regional anesthesia.

Study Design

Total Participants: 600
Study Start date:
July 01, 2020
Estimated Completion Date:
July 01, 2025

Connect with a study center

  • The Second Hospital of Shandong University

    Jinan, Shandong 250033
    China

    Active - Recruiting

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