Integrated Pulmonary Index Monitoring for Thoracic Surgery Patients

NCT05368740 | Completed FDA Device

• 1 other identifier: IPI
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the effect of postoperative Integrated Pulmonary Index (IPI) scores on postoperative complications, blood gas analysis, mortality and morbidity in the patients undergoing thoracic surgery.

Conditions

Postoperative Complications; Monitoring

Keywords

monitoring; postoperative complications; thoracic surgery; integrated pulmonary index

Outcome Measures

Primary Outcomes (2)

• number of participants with postoperative complications

  The patients were visited in the thoracic surgery service and postoperative complications were recorded.

  postoperative first 24 hours

• arterial blood pH values in the first 24 hours postoperatively

  The patients were visited in the thoracic surgery service, blood gas analyses were analysis and arterial blood pH values were recorded.

  postoperative first 24 hours

Secondary Outcomes (1)

• length of hospital stay

  through study completion, an average of 1 week"

Study Arms (2)

median IPI group

IPI score level was between 5-7

Device: integrated pulmonary index monitor

high IPI group

IPI score level was between 8-10

Device: integrated pulmonary index monitor

Interventions

integrated pulmonary index monitor DEVICE

Integrated Pulmonary Index (IPI) is a new monitoring method calculated using respiratory rate (RR), end-tidal carbon dioxide (EtCO2), peripheral oxygen saturation (SpO2), and heart rate (HR). It is designed to obtain information about the patients' oxygenation and ventilation in the form of a single value or waveform from 1 to 10 with a mathematical algorithm using fuzzy logic. According to this scoring system; 10= normal, 8-9= within normal range, 7= close to normal range, requires attention, 5-6= requires attention and may require intervention, 3-4= requires intervention, 1-2= requires immediate intervention \[2\].

Also known as: Capnostream-20, Medtronic

high IPI group; median IPI group

Eligibility Criteria

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

Study Population

All adult patients (≥ 18 years) with ASA physical status I-II class, volunteer to participate study, scheduled for elective thoracotomy and video-assisted thoracoscopic surgery (VATS) between August 1, 2020 and January 31, 2021 were included in our analysis.

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-II,
• Over 18 years,
• Scheduled for elective VATS and thoracotomy surgery under general anesthesia

You may not qualify if:

• Neuromuscular disorder,
• Serious respiratory disease,
• Serious cardiovascular disease,
• Renal failure,
• Hepatic failure,
• ASA score \> II,
• Pneumonectomy surgery,
• Morbid obesity with body mass index (BMI) \> 40 kg/m2,
• Younger than 18 years old,
• Pre-determined need for postoperative intensive care.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Mediha Türktan

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 10, 2022
• Study Start: August 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: February 1, 2021
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)