Value of Diaphragm Function Predicting Weaning From Mechanical Ventilation

NCT05632822 | Unknown

• 1 other identifier: K2603
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The reason of failure of weaning from mechanical ventilation is that their respiratory loads exceeding the capacity of their respiratory muscles. The electric activity of diaphragm (EADI) allows quantification of the neural respiratory drive to the diaphragm. The aim of this study is to evaluate diaphragmatic ultrasound related parameters and electric activity of diaphragm (EADI) during SBT and postural changes to predict weaning outcome.

Conditions

Weaning Failure; Diaphragm Defect

Keywords

Weaning Failure; Diaphragm

Outcome Measures

Primary Outcomes (1)

• EADI ( diaphragm electrical activity)

  Utilizing NAVA catheter, the EADI allows quantification of the neural respiratory drive to the diaphragm.

  30 minutes since SBT was conducted

Secondary Outcomes (2)

• Diaphragm Neurodisplacement Efficiency

  30 minutes since SBT was conducted

• Neuroventilatory Efficiency

  30 minutes since SBT was conducted

Study Arms (2)

SBT failure

The SBT was considered to be a failure if at least one the following criteria was present: (1) blood oxygen saturation (SpO2) of \<90 % with a fraction of inspired oxygen (FiO2) of≥50 %; (2) acute respiratory distress (RR≥40/min, agitation, cyanosis); (3) systolic arterial blood pressure of ≥180 mmHg; (4) cardiac arrhythmias; (5) respiratory acidosis \[pH\<7.32 with an arterial carbon dioxide tension (PaCO2) of ≥50 mmHg\].

SBT success

If none of these failure criteria was present, the SBT was considered as successfully completed.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients were intubated and ventilated for at least 48 h, who need to conduct weaning protocol.

You may qualify if:

• years old Patients with acute respiratory failure and endotracheal intubation Invasive ventilator time ≥48 hours Switched to auxiliary ventilation mode and have weaning plan.

You may not qualify if:

• Patients with severe neuromuscular diseases Patients treated with muscle relaxants Patients who have been or are about to be discontinued from life support Patients with esophageal and fundus varicose veins, digestive tract perforation or gastric tube insertion after upper digestive tract surgery contraindicated Pregnant patients.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Diao S, Li S, Dong R, Jiang W, Wang C, Chen Y, Wang J, He S, Wang Y, Du B, Weng L. The diaphragmatic electrical activity during spontaneous breathing trial in patients with mechanical ventilation: physiological description and potential clinical utility. BMC Pulm Med. 2024 May 30;24(1):263. doi: 10.1186/s12890-024-03077-8.

  PMID: 38816810 DERIVED

Study Officials

• Li Weng, Dr

  Director of department

  STUDY DIRECTOR

Central Study Contacts

Shitong Diao, Dr

CONTACT

13833117878; diaost@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: December 1, 2022
• Study Start: September 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)