Perioperative/Postoperative ComplicationsNCT04995939
Preoperative Laboratory Parameters and Scorings Systems on Postoperative Pulmonary Complications in Thoracic Surgery
An observational study of Perioperative/Postoperative Complications, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pulmonary complications (PPC) emerge as a major risk that determines the morbidity and mortality of patients after surgery. PPCs affect the length of hospital stay and increase health costs. Because of this reason, it is important to predict PPCs before surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Perioperative/Postoperative Complications
- What is being tested?
- Laboratory parameters and Scoring systems
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2021to 15 Nov 2021
- How long will I take part?
- 9 Months
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients aged 18-75 years who are scheduled for elective thoracotomy or VATS, who have not had previous thoracic surgery, and without advanced lung and heart disease.
Who may be able to join
- Patients who will undergo elective thoracotomy or video assisted thoracic surgery with general anesthesia
- BMI < 35 kg/m2
- Age 18 - 75 years old
- Expected operative time more than 60 minutes
Who cannot join
- History of lung surgery
- Advanced lung-heart disease
- Having a previous COVID-19 pneumonia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Ankara, Keçioören
About this study
Official title: Evaluation of the Effects of Preoperative Neutrophil/Lymphocyte Ratio, Albumin Level, and Various Risk Scorings on Postoperative Pulmonary Complications in Thoracic Surgery. Prospective Observational Study
Postoperative pulmonary complications (PPC) emerge as a major risk that determines the morbidity and mortality of patients after surgery. PPCs affect the length of hospital stay and increase health costs. Because of this reason, it is important to predict PPCs before surgery. There are many studies on scoring systems that can be effective in predicting PPCs. The most frequently used ones are the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk index, the Nutritional Risk Score (NRS), and the American Society of Anesthesiologist (ASA) score. ARISCAT risk index is mostly evaluated in operations performed other than thoracic surgery. Since the thoracic wall, mediastinum or lungs are directly intervened in thoracic surgery operations, the expected PPCs in these patients may be different from those expected in other surgical groups. Therefore, the ARISCAT risk index may be insufficient to evaluate PPCs in thoracic surgery.
- Being tested
- Laboratory parameters and Scoring systems
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory parameters and Scoring systemsProcedure or surgery
Neutrophil/ Lymphocite ratio, albumin level and scoring systems has been evaluated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of patients who developed one or more postoperative pulmonary complications according to preoperative neutrophil/lymphocyte ratio, albumin value, ARISCAT risk index, nutritional risk score, and ASA physical status.
- Effectiveness of the ARISCAT risk scoring index [ Time Frame: postoperative first 30 days ] to investigate the effectiveness of the ARISCAT risk scoring index in predicting the development of PPC in patients undergoing thoracic surgery.
- Correlation between ASA physical status (1-3) and PPC [ Time Frame: postoperative first 30 days ]
- Correlation between NRS ( nutritional risk score) score (0-3) and PPC [ Time Frame: postoperative first 30 days ]
- Correlation between preoperative albumin values (gram / dl) and PPC [ Time Frame: postoperative first 30 days ]
- Correlation between preoperative neutrophil/lymphocyte ratio and PPC [ Time Frame: postoperative first 30 days ]
Measured: Time to preoperative visit and through study completion, an average of three months.
Secondary outcomes (1)
Distribution of patients who developed one or more postoperative pulmonary complications according to age, gender, BMI and preoperative SpO2 level.
- Correlation between age (years) and PPC [ Time Frame: postoperative first 30 days
- Correlation between gender(male or female) and PPC [ Time Frame: postoperative first 30 days ]
- Correlation between BMI (kg/m^2) and PPC [ Time Frame: postoperative first 30 days ]
- Correlation between Preoperative Sp02(>96%, 91%-95%, <90%) and PPC [ Time Frame: postoperative first 30 days ]
Measured: Time to preoperative visit and up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start15 Mar 2021
- Primary completion15 Aug 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulay Ulger, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995939
- Sponsor's protocol ID
- 2012-KAEK-15/2230
- Status last verified
- Nov 2021
- First submitted
- 9 Jul 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ulger G, Sazak H, Baldemir R, Zengin M, Kaybal O, Incekara F, Alagoz A. The effectiveness of ARISCAT Risk Index, other scoring systems, and parameters in predicting pulmonary complications after thoracic surgery. Medicine (Baltimore). 2022 Jul 29;101(30):e29723. doi: 10.1097/MD.0000000000029723.
PubMed 35905198
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Preoperative Neutrophil/Lymphocyte Ratio, Albumin Level, and Various Risk Scorings on Postoperative Pulmonary Complications in Thoracic Surgery. Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04995939
- Acronym / sponsor ID
- 2012-KAEK-15/2230
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 9 Aug 2021 (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.
Postoperative pulmonary complications (PPC) emerge as a major risk that determines the morbidity and mortality of patients after surgery. PPCs affect the length of hospital stay and increase health costs. Because of this reason, it is important to predict PPCs before surgery. There are many studies on scoring systems that can be effective in predicting PPCs. The most frequently used ones are the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) risk index, the Nutritional Risk Score (NRS), and the American Society of Anesthesiologist (ASA) score. ARISCAT risk index is mostly evaluated in operations performed other than thoracic surgery. Since the thoracic wall, mediastinum or lungs are directly intervened in thoracic surgery operations, the expected PPCs in these patients may be different from those expected in other surgical groups. Therefore, the ARISCAT risk index may be insufficient to evaluate PPCs in thoracic surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-75 years who are scheduled for elective thoracotomy or VATS, who have not had previous thoracic surgery, and without advanced lung and heart disease.
Key inclusion criteria (4 listed)
- Patients who will undergo elective thoracotomy or video assisted thoracic surgery with general anesthesia
- BMI < 35 kg/m2
- Age 18 - 75 years old
- Expected operative time more than 60 minutes
Key exclusion criteria (3 listed)
- History of lung surgery
- Advanced lung-heart disease
- Having a previous COVID-19 pneumonia
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 |
|---|---|---|
| Laboratory parameters and Scoring systemsNeutrophil/ Lymphocite ratio, albumin level and scoring systems has been evaluated. | Procedure or surgery | – |
Primary outcome
Distribution of patients who developed one or more postoperative pulmonary complications according to preoperative neutrophil/lymphocyte ratio, albumin value, ARISCAT risk index, nutritional risk score, and ASA physical status.
Time frame: Time to preoperative visit and through study completion, an average of three months.
1. Effectiveness of the ARISCAT risk scoring index [ Time Frame: postoperative first 30 days ] to investigate the effectiveness of the ARISCAT risk scoring index in predicting the development of PPC in patients undergoing thoracic surgery. 2. Correlation between ASA physical status (1-3) and PPC [ Time Frame: postoperative first 30 days ] 3. Correlation between NRS ( nutritional risk score) score (0-3) and PPC [ Time Frame: postoperative first 30 days ] 4. Correlation between preoperative albumin values (gram / dl) and PPC [ Time Frame: postoperative first 30 days ] 5. Correlation between preoperative neutrophil/lymphocyte ratio and PPC [ Time Frame: postoperative first 30 days ]
1 secondary outcome
Distribution of patients who developed one or more postoperative pulmonary complications according to age, gender, BMI and preoperative SpO2 level.
Time frame: Time to preoperative visit and up to 30 days.
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 Feb 2022.
- Derived from this study: PubMed 35905198Ulger G, Sazak H, Baldemir R, Zengin M, Kaybal O, Incekara F, Alagoz A. The effectiveness of ARISCAT Risk Index, other scoring systems, and parameters in predicting pulmonary complications after thoracic surgery. Medicine (Baltimore). 2022 Jul 29;101(30):e29723. doi: 10.1097/MD.0000000000029723.
- 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 Perioperative/Postoperative Complications, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital 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 4 inclusion and 3 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 Feb 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?
Distribution of patients who developed one or more postoperative pulmonary complications according to preoperative neutrophil/lymphocyte ratio, albumin value, ARISCAT risk index, nutritional risk score, and ASA physical status. (time frame: Time to preoperative visit and through study completion, an average of three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04995939, which also lists 1 linked publication.
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 Feb 2022.