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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05269784
• Other study ID #: Completely Tubeless ZYP
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 1, 2025

Study information

• Verified date: February 2022
• Source: The Second Hospital of Shandong University
• Contact: Yunpeng Zhao
• Phone: 18766188692
• Email: zyp_baggio[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 1, 2025
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• ERAS
• Lung Diseases
• Surgery

Intervention

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

Locations

Country	Name	City	State
China	The Second Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

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