ERAS, Lung Diseases, Surgery
Conditions
Keywords
tubeless, enhanced recovery after surgery (ERAS), lung surgery, no intubation, urinary catheter
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.
Interventions
PROCEDUREMinimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol
Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol
PROCEDUREMinimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol
Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol
Sponsors
The Second Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urinary irritation and urinary tract infection | within a week after surgery | incidence rate |
| 0-degree discomfort | within 3 days after surgery | proportion |
| duration of postoperative hospital stay | within 7 days after surgery | days |
| pneumonia | within 7 days after surgery | incidence rate |
| operation time | within 150 minutes | minutes |
| bleeding volume | during surgery | ml ml |
| volume of drainage | within 7 days after surgery | ml |
| Pain degree | within 7 days after surgery | On a scale of 1 to 10 |
| drainage duration time | within 7 days after surgery | days |
Countries
China
Contacts
Primary ContactYunpeng Zhao
Outcome results
None listed