NCT05019079

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

July 25, 2021

Last Update Submit

August 20, 2021

Conditions

Keywords

ElectroacupunctureLung protectionventilator induced lung injury

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (19)

  • Postoperative comfort score

    during anesthesia recovery period

  • sedation score (Ramsay)

    during anesthesia recovery period

  • restfulness score (DRS)

    during anesthesia recovery period

  • visual analogue scale (VAS)

    during anesthesia recovery period

  • Length of stay

    1 week after discharge, the patient's length of stay will be recorded through medical record system

  • +14 more secondary outcomes

Study Arms (2)

electroacupuncture group

EXPERIMENTAL

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

control group

NO INTERVENTION

The patient underwent routine anesthesia without acupuncture treatment

Interventions

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.

electroacupuncture group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing general anesthesia in our hospital;
  • Ages 18-60;
  • American Society of Anesthesiologists (ASA) grade â…± \~ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Central Study Contacts

Lingling Ding, Doctor

CONTACT

Jiaqi Ning, bachelor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2021

First Posted

August 24, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2023

Last Updated

August 24, 2021

Record last verified: 2021-08