search
Back to results

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

Primary Purpose

Lung Diseases, ERAS, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol
Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol
Sponsored by
The Second Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases focused on measuring tubeless, enhanced recovery after surgery (ERAS), lung surgery, no intubation, urinary catheter

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Completely Tubeless Group

Partially Tubeless Group

Arm Description

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.

minimally invasive lung surgery under ERAS with partially tubeless protocol.

Outcomes

Primary Outcome Measures

urinary irritation and urinary tract infection
incidence rate
0-degree discomfort
proportion
duration of postoperative hospital stay
days
pneumonia
incidence rate
operation time
minutes
bleeding volume
ml ml
volume of drainage
ml
Pain degree
On a scale of 1 to 10
drainage duration time
days

Secondary Outcome Measures

Full Information

First Posted
February 26, 2022
Last Updated
November 14, 2022
Sponsor
The Second Hospital of Shandong University
search

1. Study Identification

Unique Protocol Identification Number
NCT05269784
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, ERAS, Surgery
Keywords
tubeless, enhanced recovery after surgery (ERAS), lung surgery, no intubation, urinary catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Completely Tubeless Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Partially Tubeless Group
Arm Type
Active Comparator
Arm Description
minimally invasive lung surgery under ERAS with partially tubeless protocol.
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol
Intervention Description
Minimally Invasive Lung Surgery Under ERAS With Completely Tubeless Protocol
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol
Intervention Description
Minimally Invasive Lung Surgery Under ERAS With partially Tubeless Protocol
Primary Outcome Measure Information:
Title
urinary irritation and urinary tract infection
Description
incidence rate
Time Frame
within a week after surgery
Title
0-degree discomfort
Description
proportion
Time Frame
within 3 days after surgery
Title
duration of postoperative hospital stay
Description
days
Time Frame
within 7 days after surgery
Title
pneumonia
Description
incidence rate
Time Frame
within 7 days after surgery
Title
operation time
Description
minutes
Time Frame
within 150 minutes
Title
bleeding volume
Description
ml ml
Time Frame
during surgery
Title
volume of drainage
Description
ml
Time Frame
within 7 days after surgery
Title
Pain degree
Description
On a scale of 1 to 10
Time Frame
within 7 days after surgery
Title
drainage duration time
Description
days
Time Frame
within 7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunpeng Zhao
Phone
18766188692
Email
zyp_baggio@163.com
Facility Information:
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunpeng Zhao, doctor
Phone
+8618766188692

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs