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

NCT05269784 | Unknown DMC

• 1 other identifier: Completely Tubeless ZYP
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases; ERAS; Surgery

Keywords

tubeless; enhanced recovery after surgery (ERAS); lung surgery; no intubation; urinary catheter

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

Completely Tubeless Group

EXPERIMENTAL

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

Partially Tubeless Group

ACTIVE COMPARATOR

minimally invasive lung surgery under ERAS with partially tubeless protocol.

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

Interventions

Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol PROCEDURE

Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol

Completely Tubeless Group

Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol PROCEDURE

Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol

Partially Tubeless Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

RECRUITING

Related Publications (1)

• Zhao Y, Shan L, Zhang W, Li P, Li N, Zhang H, Peng C, Cong B, Zhao X. Minimally invasive lung surgery with an intraoperative completely or partially tubeless protocol: randomized clinical trial. BJS Open. 2024 Dec 30;9(1):zrae132. doi: 10.1093/bjsopen/zrae132.

  PMID: 39924850 DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Central Study Contacts

Yunpeng Zhao

CONTACT

18766188692; zyp_baggio@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 8, 2022
• Study Start: July 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2025
• Last Updated: November 16, 2022

Record last verified: 2022-02

Locations

CN (1)