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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Failure
• Intervention / Treatment: Other: Observetional

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.

• Study Type: Observational
• Enrollment (Estimated): 70

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Included patients will receive the standard care, according to the usual standard clinical practice at the institution. 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. Any respiratory, hemodynamic events or interventions will be recorded by the ICU nurses who will be blinded for the study.Demographic ( age, gender, BMI, co morbidities), clinical, laboratory, and outcomes data will be obtained from the medical records. Routine laboratory tests were done for all patients, including CBC, C-reactive protein, renal profile, coagulation profile and liver profile.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Respiratory compromise (RC) group	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.
Non respiratory compromise (RC) group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Failure	Hypoxia; Hypercapnia	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): November 16, 2024
• Study Completion (Estimated): December 22, 2024

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: FMASU MS 136/2024.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No