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CompletedNCT05368740Updated May 16, 2022

Integrated Pulmonary Index Monitoring for Thoracic Surgery Patients

An observational study in Postoperative Complications and Monitoring, sponsored by Cukurova University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-16.

Sponsored by Cukurova University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
97
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This prospective observational clinical study was performed between August 1, 2020 and January 31, 2021. After faculty ethics committee approval (Cukurova University, decision number: 111, date 02.10.2020) and written informed patient consent, 97 patients with American Society of Anesthesiologists (ASA) physical status I-II, over 18 years, volunteer to participate study, scheduled for elective VATS and thoracotomy surgery under general anesthesia were included in this study. Exclusion criteria were the presence of neuromuscular disorder, serious respiratory, cardiovascular, renal, and hepatic disease, 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.

Routine monitoring (electrocardiogram, noninvasive arterial blood pressure, heart rate and oxygen saturation) were applied before the induction of anesthesia to all patients. The induction was with intravenously (iv) 1.5-2 mg/kg propofol and 0.6 mg/kg rocuronium. After adequate muscle relaxation, female patients were intubated with a 35-37 F, male patients were intubated with a 39-41 F double-lumen tube. Anesthesia was maintained by repeated rocuronium doses if needed, 1.5-2% sevoflurane and an oxygen-air mixture. One lung ventilation was started just before the thorax was opened.

At the end of the surgery, neuromuscular block was antagonised with neostigmine (0.05 mg/kg) and atropine (0.015 mg/kg). Following extubation, patients were brought to the postanesthetic care unit (PACU) for 2 hours. For postoperative analgesia, regional techniques were used if the patients agreed, otherwise, iv opioid and nonsteroidal anti-inflammatory drugs (NSAIDs) were applied. All patients were given 2 L/minute oxygen as a standard with a nasal cannula. Postoperative pain was assessed by Visual Analog Scale (VAS), if the patients complained of pain (VAS ≥ 4), iv 0.5 mg/kg meperidine was given as a rescue analgesia.

Age, height, body weight, BMI, ASA physical status, comorbidity, and respiratory function test values were recorded as demographic data. Surgery type, duration of anesthesia, duration of surgery, and complications also were recorded. Systolic, diastolic, and mean blood pressure, SpO2, EtCO2, IPI values (monitored with the CapnostreamTM35 portable respiratory monitor), and arterial blood gas analyzes (evaluated with the ABL800 BASIC blood gas device) were recorded at the 15, 30, 60 and 120th minutes at the PACU. After 2 hours, when patients met standard PACU discharge criteria (fully awake, stable hemodynamic and respiratory parameters, satisfaction analgesia) they were transferred to the thoracic surgery ward.

All patients were evaluated in three groups according to their IPI score: high IPI (score level 8-10) group, medium IPI (score level 5-7) group, and low IPI (score level 1-4) group. Required attention was defined as SpO2 was between 88% and 92%, RR ≤ 8 breath/minute or IPI score level was between 5 and 7. The required intervention was defined as SpO2 ≤ 88% and IPI score level was ≤ 4. Postoperatively, at 6, 12, 18 and 24th hours, hemodynamic values and arterial blood gas analyses, length of hospital stay, complications, need for intensive care and 28-day mortality were evaluated and recorded.

02

Conditions studied

  • Postoperative Complications
  • Monitoring

Keywords

  • monitoring
  • postoperative complications
  • thoracic surgery
  • integrated pulmonary index
03

In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's enrollment of 97 is below the median of 254 across 519 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Cukurova University is the lead sponsor of 247 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Neuromuscular disorder,
  2. Serious respiratory disease,
  3. Serious cardiovascular disease,
  4. Renal failure,
  5. Hepatic failure,
  6. ASA score > II,
  7. Pneumonectomy surgery,
  8. Morbid obesity with body mass index (BMI) > 40 kg/m2,
  9. Younger than 18 years old,
  10. Pre-determined need for postoperative intensive care.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
97 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Deviceintegrated pulmonary index monitor

    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

06

What researchers measure

Primary outcomes

  1. number of participants with postoperative complications

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

    Time frame: postoperative first 24 hours

  2. 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.

    Time frame: postoperative first 24 hours

Secondary outcomes

  1. length of hospital stay

    Postoperatively, the patients were visited in the thoracic surgery service everyday and length of hospital stay was recorded.

    Time frame: through study completion, an average of 1 week"

07

Study locations

1 site
  • Mediha Türktan
    Adana, 01330, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05368740
Lead sponsor
Cukurova University
Responsible party
mediha turktan (associate professor, Cukurova University) — Principal investigator
First posted
May 10, 2022
Start date
Aug 1, 2020
Primary completion
Jan 31, 2021
Completion
Feb 1, 2021
Last update
May 16, 2022

Oversight

FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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