Value of Diaphragm Function Predicting Weaning From Mechanical Ventilation

NCT ID: NCT05632822

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-01-01

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.

Detailed Description

The reason of failure of weaning from mechanical ventilation is that their respiratory loads exceeding the capacity of their respiratory muscles. 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. EADI catheter consists of a nasogastric feeding tube equipped with a multiple-array esophageal electrode that provides real time access to EADI.

Patients intubated and ventilated for at least 48 h were eligible for inclusion in the study.

After the ward physician judged that the patients' condition met the offline standard, patients were prepared to conduct spontaneous breathing trial (SBT). All recruited patients were placed EADI catheter.

The protocol started with patients ventilated on a PSV of 10 cm H2O above a positive end-expiratory pressure (PEEP) of 4-5 cm H2O. Then record ventilator parameters, EADI parameters (including maximum EADI, minimum EADI, area under the curve of the EADI during inspiratory time) and diaphragmatic ultrasound related parameters (diaphragm thickness and diaphragm displacement) respectively in the semi-seated and supine positions. Then assist was removed and a 30-minute SBT was performed with continuous positive airway pressure (CPAP) of 4-5 cm H2O at the previous level of FiO2. At 0, 1, 5, 10, 20 and 30 minutes into the SBT vital signs, ventilatory parameters (including RR, Vt, Ppeak, PEEP, P0.1, MV) were collected. Arterial blood gases were sampled at the start and the end of the SBT.

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

Patient was reconnected if signs of intolerance were present. The separation from the ventilator and the endotracheal tube was considered a success when spontaneous breathing could be sustained without any form of ventilatory support at 48h after extubation. Failure cases included patients who failed the SBT and patients requiring reintubation or any form of ventilator support (including non-invasive ventilation for post-extubation acute respiratory failure) during the first 48 h after extubation.

Conditions

Weaning Failure; Diaphragm Defect

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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 \[pH\<7.32 with an arterial carbon dioxide tension (PaCO2) of ≥50 mmHg\].

No interventions assigned to this group

SBT success

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Weng, Dr

Role: STUDY_DIRECTOR

Director of department

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shitong Diao, Dr

Role: CONTACT

diaost@foxmail.com

13833117878

Facility Contacts

Longfang Miao

Role: primary

pumchkyc@126.com

69156874

References

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.

Reference Type: DERIVED

PMID: 38816810 (View on PubMed)

Other Identifiers

K2603

Identifier Type: -

Identifier Source: org_study_id