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

NCT06395532 | Not Yet Recruiting

• 1 other identifier: FMASU MS 136/2024.
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Respiratory Failure

  1. Hypoxia 2. Hypercapnia

  6 months

Secondary Outcomes (1)

• Complications

  6 months

Study Arms (2)

Respiratory compromise (RC) group

Other: Observetional

Non respiratory compromise (RC) group

Other: Observetional

Interventions

Observetional 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; Respiratory compromise (RC) group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Age \< 18 years' old
• Morbid obesity
• Mechanical ventilation
• Hemodynamic instability.
• Thoracotomy and cardiac surgery

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 2, 2024
• Study Start: May 15, 2024
• Primary Completion: November 16, 2024
• Study Completion: December 22, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04