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IRCT20230208057359N1 IRCT 2023-02-13 Karaj University of Medical Sciences Comparison of the Outcome of Using One-way Heimlich Valve in the Treatment of Primary Spontaneous Pneumothorax in Comparison with Implantation of Chest Tube and Connection to the Bottle Comparison of the Outcome of Using One-way Heimlich Valve in the Treatment of Primary Spontaneous Pneumothorax in Comparison with Implantation of Chest Tube and Connection to the Bottle, A Randomized Clinical Trial 2023-03-21 anticipated 40 Complete https://irct.ir/trial/68520 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants with the collapse below 50% were randomly assigned to two treatment groups with chest tube insertion or One-way Heimlich Valve insertion, and participants with collapse above 50% were randomly assigned to two treatment groups with chest tube insertion or One-way Heimlich Valve insertion (stratified randomization). For randomization, the block randomization method will be used, so that at first in the Excel software, blocks of four will be prepared as (AABB) (BBAA) (ABBA) (BAAB) (ABAB) (BABA). A indicates the group of One-way Heimlich Valve and B indicates the group of the chest tube connected to the Bottle. Then one of the blocks will be randomly selected and based on the sequence of letters in the selected block, the eligible people will be assigned to the treatment groups. This random process of selecting blocks and assigning people to treatment groups will continue until the desired sample size is reached. The preparation of the random allocation sequences of these two intervention groups and placing them in sealed envelopes and numbering with a 5-digit serial number is done by a third person who is not involved in the design of the study. All the envelopes have a 5-digit serial number, which are opened after recording background information, and the sample participants are divided into two intervention groups, Blinding description: This study will be double-blinded, so that the evaluator and the participants are not aware of the status of assigning participants to the study groups. It will be explained to the study subjects before the random assignment, how the work process is, and they may receive one of the two treatments randomly, and the treatment used for the individual is not known in advance. It will not be possible for the patients to distinguish these treatments from each other. Also, the outcome evaluator will be blinded about assigning participants to the study groups. 3 Primary Spontaneous Pneumothorax. Intervention 1: For the participants in the first intervention group, chest tube number 28 will be inserted from the fourth or fifth intercostal space in the area of ​​the anterior to mid-axillary line and it will be connected to the bottle. Patients will receive supportive treatments such as incentive spirometry and respiratory physiotherapy, and they will be prescribed oral acetaminophen 10 mg per kilogram of weight. In case of shortness of breath, they will receive nasal oxygen. Intervention 2: For participants in the second intervention group, tube number 28 will be inserted from the fourth or fifth intercostal space in the area of ​​the anterior to mid-axillary line and it will be and connected to the one-way Heimlich valve. Patients will receive supportive treatments such as incentive spirometry and respiratory physiotherapy, and they will be prescribed oral acetaminophen 10 mg per kilogram of weight. In case of shortness of breath, they will receive nasal oxygen. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is A decision has not yet been made regarding the publication of the data file of the participants, and a decision will be made after the completion of the study.
public Seyed Mohammad Naghibalghora Banadaki
Shahid Madani Hospital, Shahid Madani Square, Mahan Boulevard, Taleghani Crossroad, Karaj
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3442 7001 m.naghib@abzums.ac.ir Karaj University of Medical Sciences scientific Seyed Mohammad Naghibalghora Banadaki
Shahid Madani Hospital, Shahid Madani Square, Mahan Boulevard, Taleghani Crossroad, Karaj
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3442 7001 m.naghib@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Patients aged 18 to 40 years old with Primary Spontaneous Pneumothorax that is symptomatic and the lung collapse rate is more than 15% (the distance between the chest wall and the lung is more than 1 cm) No history of trauma in the last month No history of severe asthma or chronic obstructive pulmonary disease Not suffering from psychosis Do not require special medical services such as hospitalization in ICU Do not have complete lung collapse Not breastfeeding or pregnant 18 years 40 years Both Patients who are eligible to enter the study but did not consent to enter the study Patients who developed complications and the patient's treatment was discontinued Patients in need of Video-assisted thoracoscopic surgery include having one lung, being a diver or a pilot, having a large Pulmonary Embolus Treatment failure after 7 days J93.11 Primary spontaneous pneumothorax Treatment - Surgery Treatment - Surgery For the participants in the first intervention group, chest tube number 28 will be inserted from the fourth or fifth intercostal space in the area of ​​the anterior to mid-axillary line and it will be connected to the bottle. Patients will receive supportive treatments such as incentive spirometry and respiratory physiotherapy, and they will be prescribed oral acetaminophen 10 mg per kilogram of weight. In case of shortness of breath, they will receive nasal oxygen. For participants in the second intervention group, tube number 28 will be inserted from the fourth or fifth intercostal space in the area of ​​the anterior to mid-axillary line and it will be and connected to the one-way Heimlich valve. Patients will receive supportive treatments such as incentive spirometry and respiratory physiotherapy, and they will be prescribed oral acetaminophen 10 mg per kilogram of weight. In case of shortness of breath, they will receive nasal oxygen. The hospitalization duration from the start of treatment until the time of removal of the chest tube. Timepoint: When the chest tube is removed, the hospitalization duration is calculated. Method of measurement: Days recorded in the patient's file. Pain Severity. Timepoint: Daily examination during hospitalization and weekly after discharge for up to 4 weeks. Method of measurement: Visual Analogue Scale score (0 to 10). Readmission. Timepoint: Weekly from the time of discharge up to 4 weeks. Method of measurement: Based on examinations, symptoms and paraclinical measures. Treatment failure. Timepoint: 7 days after the intervention. Method of measurement: No symptom improvement or incomplete opening of the lung after 7 days is considered as treatment failure. Complications. Timepoint: Daily examination during hospitalization and weekly after discharge for up to 4 weeks. Method of measurement: Occurrence of complications including subcutaneous Emphysema, Hematoma and wound infection through examination and clinical symptoms. Shortness of breath severity. Timepoint: Daily examination during hospitalization and weekly after discharge for up to 4 weeks. Method of measurement: Visual Analogue Scale score (0 to 10). Ketorolac injection. Timepoint: Daily examination during hospitalization. Method of measurement: The number of requests and the milligrams of the injected Ketorolac. Karaj University of Medical Sciences Approved 2023-01-08 Ethics committee of Alborz University of Medical Sciences Ethics Committee Unit, Research and Technology Department of Alborz University of Medical Sciences, No 20, Safarian Alley, Golshahr Street, Karaj Karaj Alborz Iran (Islamic Republic of)