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

Sponsor

Jilai Xiao (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06049173

Collaborator

(none)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.
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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pulmonary Atelectasis	Other: novel recruitment maneuver therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Pulmonary ultrasound [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanjing First Hospital	Nanjing	Nanjing	China	210000

Sponsors and Collaborators

Jilai Xiao

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Jilai Xiao, associate chief physician, Nanjing First Hospital, Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT06049173

Other Study ID Numbers:

KY20230829-04

First Posted:

Sep 22, 2023

Last Update Posted:

Sep 22, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Atelectasis

Study Results

No Results Posted as of Sep 22, 2023