PMI Guide PS Setting in Pressure Support-ventilated Patients

NCT05963737 | Recruiting DMC

• 1 other identifier: KY2023-005-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pressure support ventilation (PSV) is an assistant mechanical ventilation mode, that is widely implemented in mechanical ventilation treatment but there are no exact guidelines to guide PS setting. Traditional PS setting strategy (VT/PBW 6-8ml/kg and RR 20-30 breaths/min)has risks of excessive or insufficient assistance. Inspiratory muscle pressure index (PMI) is a noninvasive respiratory mechanical indicator and is available at the bedside. PMI was correlated with inspiratory effort and has the potential ability to predict low inspiratory effort and high inspiratory effort. The primary objective of this study is to investigate the clinical validity of a PMI-guided PS setting strategy. Specifically, the investigators aim to evaluate its impact on inspiratory effort as well as its potential for lung and diaphragm protection. Additionally, the investigators seek to assess the effect of this ventilation strategy on mechanical ventilation outcomes while evaluating the feasibility of our trial protocol.

Conditions

Mechanical Ventilation

Keywords

pressure support ventilation; inspiratory effort; inspiratory muscle pressure index

Outcome Measures

Primary Outcomes (1)

• The proportion of conditions in the range of normal inspiratory effort per patient

  the time from the start of PSV mode to the successful weaning of the ventilated patients

  up to 48 hours

Secondary Outcomes (9)

• The duration of mechanical ventilation

  up to 28 days

• Tracheostomy rate

  up to 28 days

• Reintubation rate

  up to 28 days

• Diaphragm thickness (Tdi)

  up to 28 days

• Diaphragm thicken fraction (TFdi)

  up to 28 days

Study Arms (2)

Experimental arm

EXPERIMENTAL

The initial PS level is set up based on VT/PBW (6-8ml/kg) and RR (20-30 breaths/min) when patients are enrolled in the experimental arm. The following steps need to be repeated every 2 hours for 48 hours. Step 1: 3 times short EIOs (2-3s) are performed. At least 1 minute between each occlusion. PMI is calculated as the mean value of 3 measured values. Step 2: Clarify whether PMI is in the target range (PMI 0-2cmH2O). If yes, keep this PS level. If not, implement step 3. Step 3: A downward or upward PS setting adjustment is performed at a 1cmH2O interval. Every PS level is maintained for 3-5 minutes. PMI is measured again and step 3 is repeated until the PMI target is reached. Step 4: supplemental adjustment: PS setting needs to be returned to the previous level if the patient presents the following signs: VT \< 4 ml/Kg, RR \> 35 breaths/min, respiratory acidosis, respiratory distress, VT \> 10ml/Kg, Pplat \> 30 cmH2O, respiratory alkalosis.

Procedure: PS setting strategy in pressure-support ventilated patients

Control arm

NO INTERVENTION

Patients randomized to the control arm need to continue to accept the traditional ventilation strategy which is VT/PBW (6-8ml/kg) and RR (20-30breaths/min) guide PS setting.

Interventions

PS setting strategy in pressure-support ventilated patients PROCEDURE

Use PMI guide PS setting in pressure-supported ventilated patients and keep PMI within the target range (0-2cmH2O).

Experimental arm

Eligibility Criteria

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

You may qualify if:

• Patients under PSV
• Predicted ventilated time of more than 48 hours.

You may not qualify if:

• Age less than 18 years old;
• Known pregnancy;
• BMI\>35kg/m2;
• Brain-stem or cervical cord injury;
• Known or clinically suspected elevated intracranial pressure (ICP\>18 mmHg);
• Nervus phrenicus or diaphragm injury;
• Broncho-pleural fistula;
• Chronic obstructive pulmonary disease (COPD);
• Pressure support ventilated time more than 48 hours before randomization.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

Related Publications (1)

• Gao R, Yang YL, Zhang L, Miao MY, Zhou JX. Use of pressure muscle index to guide pressure support ventilation setting: a study protocol and statistical plan for a prospective randomised controlled proof-of-concept trial. BMJ Open. 2024 Aug 3;14(8):e082395. doi: 10.1136/bmjopen-2023-082395.

  PMID: 39097307 DERIVED

Study Design

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

Study Record Dates

• First Submitted: July 1, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: January 9, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)