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Postoperative ComplicationsNCT05368740

Integrated Pulmonary Index Monitoring for Thoracic Surgery Patients

An observational study of Postoperative Complications and Monitoring, run by Cukurova University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Complications, Monitoring
What is being tested?
integrated pulmonary index monitor
Type of treatment
Medical device
How many people
97 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2020to 1 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Neuromuscular disorder,
  • Serious respiratory disease,
  • Serious cardiovascular disease,
  • Renal failure,
  • Hepatic failure,
  • ASA score > II,
Show all 10Show fewer
  • Pneumonectomy surgery,
  • Morbid obesity with body mass index (BMI) > 40 kg/m2,
  • Younger than 18 years old,
  • Pre-determined need for postoperative intensive care.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mediha Türktan

    Adana, 01330

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Thoracic Surgery Patients With Integrated Pulmonary Index: A Prospective, Observational Study

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.

Being tested
integrated pulmonary index monitor
Keywords
monitoring, postoperative complications, thoracic surgery, integrated pulmonary index
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • integrated pulmonary index monitorDevice

    Also called Capnostream-20, Medtronic

    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].

Study groups in NCT05368740
Study groupRoleWhat they receive
median IPI groupIPI score level was between 5-7
Receives: Device: integrated pulmonary index monitor
high IPI groupIPI score level was between 8-10
Receives: Device: integrated pulmonary index monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of participants with postoperative complications

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

    Measured: 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.

    Measured: postoperative first 24 hours

Secondary outcomes (1)
  1. length of hospital stay

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

    Measured: through study completion, an average of 1 week"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2022
  2. Study start1 Aug 2020
  3. Primary completion31 Jan 2021
  4. Study completion1 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05368740
Sponsor's protocol ID
IPI
Status last verified
May 2022
First submitted
22 Apr 2022
Last updated
16 May 2022
Results posted
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Complications and Monitoring, run by Cukurova University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of participants with postoperative complications (time frame: postoperative first 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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