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CompletedNCT04995939Updated Feb 16, 2022

Preoperative Laboratory Parameters and Scorings Systems on Postoperative Pulmonary Complications in Thoracic Surgery

An observational study in Perioperative/Postoperative Complications, sponsored by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-02-16.

Sponsored by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years to 75 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Perioperative/Postoperative Complications
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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 130 is below the median of 254 across 519 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital is the lead sponsor of 28 studies on the registry; 10 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • History of lung surgery
  • Advanced lung-heart disease
  • Having a previous COVID-19 pneumonia
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (actual)
Target follow-up
9 Months
Patient registry
Yes

Interventions

  • ProcedureLaboratory parameters and Scoring systems

    Neutrophil/ Lymphocite ratio, albumin level and scoring systems has been evaluated.

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What researchers measure

Primary outcomes

  1. 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.

    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 \[ Time Frame: postoperative first 30 days \]

    Time frame: 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.

    1. Correlation between age (years) and PPC \[ Time Frame: postoperative first 30 days 2. Correlation between gender(male or female) and PPC \[ Time Frame: postoperative first 30 days \] 3. Correlation between BMI (kg/m\^2) and PPC \[ Time Frame: postoperative first 30 days \] 4. Correlation between Preoperative Sp02(\>96%, 91%-95%, \<90%) and PPC \[ Time Frame: postoperative first 30 days \]

    Time frame: Time to preoperative visit and up to 30 days.

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Study locations

1 site
  • Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
    Ankara, Keçioören, Turkey
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

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

Key details

Study ID
NCT04995939
Lead sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Responsible party
Gulay Ulger (Principal investigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital) — Principal investigator
First posted
Aug 9, 2021
Start date
Mar 15, 2021
Primary completion
Aug 15, 2021
Completion
Nov 15, 2021
Last update
Feb 16, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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