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Search / Trial NCT06282003

Protective Anesthesiological Management Procedure Imposes Control on Respiratory Comlications

Launched by MASA KONTIC · Feb 20, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

General Anaesthesia Intraoperative Complications Postoperative Complications Lung Recruitment Procedure Therapeutic Positive Pressure Ventilation

ClinConnect Summary

This clinical trial is looking at how different anesthesia methods can help prevent breathing problems after surgery, especially for patients undergoing abdominal surgery. The study compares two approaches: the Conventional Ventilation (CV) method, which uses more oxygen during surgery, and the Protective Lung Ventilation (PV) method, which focuses on keeping the lungs healthy with special techniques. Researchers hope that by using the PV method, they can lower the chances of patients experiencing respiratory complications after their procedures.

To be eligible for this trial, participants should be healthy adults aged 18 to 65 who are scheduled for colorectal cancer surgery and meet specific health criteria, such as having stable blood pressure and controlled diabetes. Patients will need to provide informed consent to participate. If they join the study, they can expect to be randomly assigned to one of the two anesthesia methods and monitored closely to see which approach better protects their lung function during and after surgery. This trial is important as it aims to improve standard practices for anesthesia, ensuring safer outcomes for patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * the inclusion criteria were as follows:
  • subject status according to the American Society of Anesthesiologists Association classification
  • ASA 1 (normal healthy patients, i.e. patients without associated comorbidities) or ASA 2 (patients with mild systemic disease, such as well-controlled hypertension), normal heart and lung function, both sexes,
  • non-smokers, normal X-ray findings for heart and lungs,
  • age 18-65 years,
  • planned operation of medial laparotomy for colorectal cancer with a minimum duration of anesthesia of at least one hour,
  • signed informed consent.
  • In the case of hypertension in ASA 2 patients enrolled in the study, by examining the self-monitoring diary for the past three months (as described in Gropper et al., 2019), there was no increase in systolic pressure more than 20 mmHg from the average daily value and no increase in diastolic arterial pressure more than 10 mmHg from the average daily value.
  • In the case of diabetes type II in ASA 2 patients enrolled in the study, the HbA1c values were not higher than 7% while taking oral hypoglycemic drugs and having a regulated diet. The patients enrolled also had no complications or episodes of hypoglycemia in the past three months, as described by Gropper et al., 2019.
  • In the case of thyroid disease in ASA 2 patients enrolled in the study, values of TSH, fT3, and fT4 in the period up to 6 months since the last examination were normal.
  • Exclusion Criteria:
  • ASA 4 status
  • terminal renal illness
  • cardiac status NYHA III i NYHA IV
  • at home oxygenotherapy during 16 hours

About Masa Kontic

Masa Kontic is a dedicated clinical trial sponsor focused on advancing innovative therapies in the healthcare sector. With a commitment to rigorous research and development, Masa Kontic collaborates with leading academic institutions and healthcare professionals to conduct high-quality clinical trials. The organization emphasizes patient safety and ethical standards, ensuring that all studies are designed to yield meaningful data that can contribute to the improvement of patient outcomes. Through its strategic approach and expertise, Masa Kontic aims to drive medical advancements and enhance the quality of care across various therapeutic areas.

Locations

Zabok, , Croatia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported