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

NCT ID: NCT06395532

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2024-12-22

Brief 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.

Detailed 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.

Conditions

Respiratory Failure

Study Design

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

Study Groups

Respiratory compromise (RC) group

Observetional

Intervention Type: OTHER

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.

Non respiratory compromise (RC) group

Observetional

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Hanaa Mohamed Abdallah ElGendy MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FMASU MS 136/2024.

Identifier Type: -

Identifier Source: org_study_id