Protective Effect of Electroacupuncture on Lung in Patients Undergoing General Anesthesia

Objective to investigate the protective effect of preoperative electroacupuncture on lung function in patients with mechanical ventilation for more than 2 hours under general anesthesia

Study Overview

• Status: Not yet recruiting
• Conditions: Electroacupuncture; Lung Injury, Ventilator Induced
• Intervention / Treatment: Other: electroacupuncture

Detailed Description

Randomized parallel control study. From September 1, 2021 to December 31, 2022, patients with mechanical ventilation time more than 2 hours will be randomly divided into electroacupuncture pretreatment group and blank control group. The blood gas index, ventilator parameters and serum inflammatory factor concentration of patients will be evaluated to evaluate whether electroacupuncture has protective effect on lung function of patients with mechanical ventilation.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lingling Ding, Doctor; Phone Number: +86 010 52176647; Email: dinglingling301@126.com
• Study Contact Backup: Name: Jiaqi Ning, bachelor; Phone Number: +86 010 52176647; Email: ningjiaqi95@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing general anesthesia in our hospital;
• Ages 18-60;
• American Society of Anesthesiologists (ASA) grade ⅱ ~ III , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
• Expected duration of operation >2h;
• Surgical grade 2-4;
• No serious lung infection and lung disease;
• Body mass index (BMI) 18~30 kg/m2; There are no contraindications for electroacupuncture stimulation.

Exclusion Criteria:

• Patients with severe circulatory or other system dysfunction;
• Patients with pulmonary and one-lung ventilation;
• Unwilling to cooperate with the patient;
• Patients with low compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: electroacupuncture group; In the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation was stopped 30min later.	Other: electroacupuncture; In the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation will be stopped 30min later.
No Intervention: control group; The patient underwent routine anesthesia without acupuncture treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygenation index	record oxygenation index	Before anesthesia
oxygenation index	record oxygenation index	2 hours after tracheal intubation
oxygenation index	record oxygenation index	5 minutes after tracheal intubation removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative comfort score	Assess the quality of recovery during recovery	during anesthesia recovery period
sedation score (Ramsay)	Assess the quality of recovery during recovery	during anesthesia recovery period
restfulness score (DRS)	Assess the quality of recovery during recovery	during anesthesia recovery period
visual analogue scale (VAS)	Assess the quality of recovery during recovery	during anesthesia recovery period
Length of stay	Assess the quality of postoperative recovery	1 week after discharge, the patient's length of stay will be recorded through medical record system
postoperative time in hospital	Assess the quality of postoperative recovery	1 week after discharge, the patient's postoperative time in hospital will be recorded through medical record system
postoperative complications of major organs	Assess the quality of postoperative recovery	Major organ complications during hospitalization，assessed up to 30 days after surgery
mortality within 30 days	Assess the quality of postoperative recovery	mortality within 30 days will be recorded
Expression of IL-18 in serum	The perioperative inflammation level will be assessed	Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-18 in serum will be detected by flow cytometry
Expression of IL-18 in serum	The perioperative inflammation level will be assessed	5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-18 in serum will be detected by flow cytometry
Expression of IL-1β in serum	The perioperative inflammation level will be assessed	Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-1β in serum will be detected by flow cytometry
Expression of IL-1β in serum	The perioperative inflammation level will be assessed	5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-1β in serum will be detected by flow cytometry
Expression of IL-10 in serum	The perioperative inflammation level will be assessed	Before anesthetic induction the radial artery blood samples will be collected, and the expressions of IL-10 in serum will be detected by flow cytometry
Expression of IL-10 in serum	The perioperative inflammation level will be assessed	5minutes after tracheal intubation removal the radial artery blood samples will be collected, and the expressions of IL-10 in serum will be detected by flow cytometry
Mean arterial pressure	Intraoperative vital signs will be recorded	Before anesthesia ,2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
heart rate	Intraoperative vital signs will be recorded	Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
BIS	Intraoperative vital signs will be recorded	Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
extubation time	Intraoperative vital signs will be recorded	Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal
anesthesia dosage	Intraoperative vital signs will be recorded	Before anesthesia , 2 hours after tracheal intubation , and 5minutes after tracheal intubation removal

Collaborators and Investigators

• Sponsor: Lingling Ding

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: August 20, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Electroacupuncture; Lung protection; ventilator induced lung injury
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: LDing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No