Integrated Pulmonary Index as a Predictor of Respiratory Compromise in Critically Ill Patients

Respiratory Failure Clinical Trial

Official title:

Integrated Pulmonary Index as a Predictor of Respiratory Compromise in Critically Ill Patients: A Prospective, Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395532
• Other study ID #: FMASU MS 136/2024.
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: December 22, 2024

Study information

• Verified date: April 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The integrated pulmonary index (IPI) is a newly developed index for respiratory monitoring. However, there is limited evidence on its effectiveness and usefulness in critically ill patients. The purpose of this study is to evaluate the clinical relevance of the IPI as a predictor of respiratory compromise in critically ill patients.

Description:

Recent developments aim to use multiple parameters to detect AREs. Application of smart algorithms that combine individual physiological variables into one index may increase the ability to detect a true adverse respiratory event while avoiding false alarms and limiting alarm fatigue.

An example of such a multiparameter index is the Integrated Pulmonary Index or IPI™, which integrates oxygen saturation (SpO2), respiratory rate (RR), end-tidal PCO2 (PETCO2) and heart rate (HR) into a single integer value of 1-10 that represents adequacy of respiratory condition of the patient using a fuzzy logic inference mathematical model; scores ≥ 8 points are within normal range and those ≤ 4 points suggest requirement of interventions.

The IPI algorithm summarizes the state of ventilation and oxygenation at the point in time. Previous studies reported that IPI correlated with respiratory physiological parameters of patients undergoing sedation for surgeries or for colonoscopy.

Up to our knowledge, the clinical relevance of the IPI as a predictor of respiratory compromise in critically ill patients has not been discussed before.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 22, 2024
• Est. primary completion date: November 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Critically ill patients aged 18 years or older of both genders admitted to the intensive care unit

Exclusion Criteria:

• Age < 18 years' old

• Morbid obesity

• Mechanical ventilation

• Hemodynamic instability.

• Thoracotomy and cardiac surgery

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Observetional
After admission to the ICU, patients will be continuously monitored with ICU standard monitoring in addition to IPI using (Capnostream™ Medtronic). IPI will be recorded after transfer to the ICU, as well as at 2, 6, 12, 18 and 24 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory Failure	Hypoxia; Hypercapnia	6 months
Secondary	Complications	The onset of Mechanical ventilation; The Duration of Mechanical ventilation; lCU length of stay; Hospital length of stay 5-28 days mortality	6 months