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).
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.
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.
- Conditions
- Postoperative Complications, Monitoring
- 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 group | Role | What they receive |
|---|---|---|
| median IPI group | IPI score level was between 5-7 Receives: Device: integrated pulmonary index monitor | |
| high IPI group | IPI 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.
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
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)
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.
- First posted10 May 2022
- Study start1 Aug 2020
- Primary completion31 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mediha turktan, Cukurova University
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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thoracic Surgery Patients With Integrated Pulmonary Index: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05368740
- Acronym / sponsor ID
- IPI
- Conditions
- Postoperative Complications, Monitoring
- Keywords
- monitoring, postoperative complications, thoracic surgery, integrated pulmonary index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| median IPI group | – | Device: integrated pulmonary index monitorIPI score level was between 5-7 |
| high IPI group | – | Device: integrated pulmonary index monitorIPI score level was between 8-10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I-II,
- Over 18 years,
- Scheduled for elective VATS and thoracotomy surgery under general anesthesia
Key exclusion criteria (10 listed)
- Neuromuscular disorder,
- Serious respiratory disease,
- Serious cardiovascular disease,
- Renal failure,
- Hepatic failure,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated pulmonary index monitorAlso: Capnostream-20, MedtronicIntegrated 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]. | Device | high IPI group, median IPI group |
Primary outcome
number of participants with postoperative complications
Time frame: postoperative first 24 hours
The patients were visited in the thoracic surgery service and postoperative complications were recorded.
arterial blood pH values in the first 24 hours postoperatively
Time frame: postoperative first 24 hours
The patients were visited in the thoracic surgery service, blood gas analyses were analysis and arterial blood pH values were recorded.
1 secondary outcome
length of hospital stay
Time frame: through study completion, an average of 1 week"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.