The effect of two different methods of pleural space catheter insertion on its consequences in critical care patients with and without ultrasound guidance: A clinical trial

Determining the effect of two different catheterization methods on outcomes with and without ultrasound guidance in critically ill intensive care patients

Randomized controlled clinical trial, 68 patients

After receiving the code of ethics, the researcher will first be trained for one month under the supervision of a specialist so that he can independently insert a catheter into the patient. Initially, eighty patients will be selected, and after the researcher's training period, their number will increase to sixty-eight. During this period, the number of patients will not be included in the study. The patients' medical history will be reviewed, and all patients will undergo examinations including coagulation status and chest x-ray before and after the operation. The patient in the control group will undergo catheterization without ultrasound guidance and the patient in the experimental group will undergo catheterization with ultrasound guidance. After the catheter is inserted, its location will be confirmed with ultrasound and a chest x-ray will also be taken. Then, patients are monitored for complications and, according to the established goals, primary and secondary outcomes in patients are examined.

• Inclusion criteria: 1. Admission to the intensive care unit 2. Presence of pleural effusion • Exclusion criteria: 1. Patients with clinical instability 2. Presence of coagulopathy 3. Infection at the catheter site 4. Patient dissatisfaction

Control group: Pleural catheter insertion without ultrasound guidance Intervention group: Pleural catheter insertion with ultrasound guidance

Fluid drainage rate, bleeding, infection, number of attempts, pneumothorax, length of ICU stay, length of ventilator dependency

After obtaining ethical approval and coordination with the head nurse and the intensive care unit officials, patients will be selected according to the inclusion criteria. Then, if they are conscious, the patient or their legal guardian will be spoken to and with informed written consent, the patients will be separated based on the random allocation method. In order to randomly allocate to the two experimental and control groups, a block randomization method with blocks of four was used. In this way, the experimental group was assigned to B and the control group to A, and in blocks of four with the letters A and B, six cases ABBA, AABB, ABAB, BABA,BBAA, BAAB were written on separate sheets of paper and dropped into a container. One of these sheets was randomly taken out of the container and the combination written on it was written down and that sheet was dropped into the container again. Since the sample size in this study is 68 patients, this operation was repeated seventeen times and each time the combination written on each sheet was recorded in the sequence of the combination written on the previous sheet. Then, each letter was assigned a number from one to sixty-eight in the order of the letters written down in a row, and each letter was placed in an envelope and its number was written on the envelope. Each time a patient was selected, one of these envelopes was opened in the order of the number written on the envelope, and it was determined whether the patient should be placed in the experimental or control group.

In this study, patient blinding was implemented. This means that the patients were unaware of the treatment method (whether ultrasound-guided or non-ultrasound guided) they received. The anesthesiologist performing the catheter insertion was aware of the treatment assigned to each patient, but no bias influenced the execution of the procedure. Additionally, to avoid potential researcher bias, all clinical assessments and data collection were performed without knowledge of the treatment group.

No more information available.Protecting patient privacy and ensuring the security of their medical information are among our primary priorities. Furthermore, in accordance with data protection laws and ethical guidelines, the release of these data could lead to breaches of patient privacy. Additionally, not sharing IPD is a practical decision due to the technical complexities and high costs associated with data processing and anonymization, as well as security considerations.