Clinical trial NCT05269784: Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol Compared With That With Partially Tubeless Protocol
Official title: Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol Compared With That With Partially Tubeless Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases
ERAS
Surgery
Keywords: tubeless
enhanced recovery after surgery (ERAS)
lung surgery
no intubation
urinary catheter
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: urinary irritation and urinary tract infection
timeFrame: within a week after surgery
measure: 0-degree discomfort
timeFrame: within 3 days after surgery
measure: duration of postoperative hospital stay
timeFrame: within 7 days after surgery
measure: pneumonia
timeFrame: within 7 days after surgery
measure: operation time
timeFrame: within 150 minutes
measure: bleeding volume
timeFrame: during surgery
measure: volume of drainage
timeFrame: within 7 days after surgery
measure: Pain degree
timeFrame: within 7 days after surgery
measure: drainage duration time
timeFrame: within 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
Study officials:
References: