Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis

September 19, 2023 updated by: Jilai Xiao

Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis in the Patients With Cardiac Surgery

  1. Oxygenation index and bedside ultrasound would be used to evaluate the therapeutic effect of novel recruitment maneuver therapy in the patients with pulmonary atelectasis after cardiac surgery.
  2. To establish a new therapy strategy for pulmonary atelectasis after cardiac surgery and to evaluate its effectiveness and safety for the cardiac patients complicated with postoperative pulmonary atelectasis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Nanjing
      • Nanjing, Nanjing, China, 210000
        • Nanjing First Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • chest radiograph and bedside ultrasound indicated atelectasis After cardiac surgery and cardiopulmonary bypass Circulation is basically stable (VIS score <20)

Exclusion Criteria:

  • Presence of abdominal trauma Have a history of severe gastrointestinal disease or gastrointestinal surgery Bring into IABP（Intra-Aortic Balloon Pump）or ECMO（Extracorporeal membrane oxygenation）after operation Other conditions determined by the investigator to be unsuitable for participation in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: novel recruitment maneuver therapy
The use of abdominal compression cardiopulmonary resuscitation apparatus for new recruitment maneuver therapy: the use of autonomous ventilation mode (PSV or CPAP) during mechanical ventilation, followed by abdominal compression recruitment maneuver therapy, the number of times of each compression is 5-10, each time the duration of 30 to 40s, and then adjust to the previous breathing pattern.
Other: novel recruitment maneuver therapy
The use of abdominal compression cardiopulmonary resuscitation apparatus for new recruitment maneuver therapy: the use of autonomous ventilation mode (PSV or CPAP) during mechanical ventilation, followed by abdominal compression recruitment maneuver therapy, the number of times of each compression is 5-10, each time the duration of 30 to 40s, and then adjust to the previous breathing pattern.
No Intervention: control group
The automatic ventilation mode (PSV or CPAP) is used during mechanical ventilation, with the pressure support set to 0 cmH2O and the positive end-expiratory pressure set to 30 to 45 cmH2O for 30 to 40s, and then adjusted to the previous breathing pattern.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary ultrasound
Time Frame: 1 hour before treatment and 1 hour after treatment
Pulmonary ultrasound score (LUS score) , minimum value 0 to maximum value 36. The higher the score, the more severe the loss of lung ventilation
1 hour before treatment and 1 hour after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jilai Xiao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 10, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20230829-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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