Blinded box device used in medical gas related clinical trials to complete blinding

Abstract

The utility model belongs to the field of clinical test technology, provide a kind of blind box device used in medical gas related clinical test for completion blind method, including blind box lid, blind box body, blind box lid is arranged at the top of blind box body, the outside of blind box body is provided with two groups of external input pipeline and two groups of external output pipeline, the inside of blind box body is provided with two groups of internal pipeline, two external input pipeline respectively with the one end of two internal pipeline intercommunication, two external output pipeline respectively with the other end of two internal pipeline intercommunication;The one end of two external input pipeline away from internal pipeline is respectively communicated with research gas supply equipment, control gas supply equipment, the one end of one external output pipeline away from internal pipeline supplies gas to subject, the one end of another external output pipeline away from internal pipeline is communicated harmless treatment equipment.The utility model by two different gases are introduced into blind box device, so that subject or researcher cannot obtain gas type, complete blind method.

Description

Technical Field

[0001] This invention belongs to the field of clinical trial technology, and in particular relates to a blind box device used in clinical trials related to medical gases to complete the blinding process. Background Technology

[0002] Clinical trials studying the therapeutic effects of medical gases such as oxygen, hydrogen-oxygen mixtures, nitrogen, and carbon dioxide require a double-blind approach. This ensures that neither researchers nor participants know which gas is being used. Previous double-blind protocols have used control machines with identical appearances. For example, clinical trials studying the therapeutic effects of hydrogen-oxygen mixtures require an air control machine with the same appearance as a hydrogen-oxygen nebulizer. Such machines need to be custom-made by specialized research manufacturers, which are expensive and difficult to obtain. Utility Model Content

[0003] The purpose of this invention is to provide a blind box device for completing the blinding process in clinical trials related to medical gases, in order to solve the above-mentioned problems.

[0004] To achieve the above objectives, this utility model provides the following solution: a blind box device used in clinical trials related to medical gases to complete the blinding process, comprising a blind box lid and a blind box body, wherein the blind box lid is disposed above the blind box body, the outside of the blind box body is provided with two sets of external input pipes and two sets of external output pipes, and the inside of the blind box body is provided with two sets of internal pipes, wherein the two external input pipes are respectively connected to one end of the two internal pipes, and the two external output pipes are respectively connected to the other end of the two internal pipes;

[0005] The ends of the two external input pipes that are away from the internal pipes are respectively connected to the research gas supply device and the control gas supply device. The end of one external output pipe that is away from the internal pipe supplies gas to the subject, and the end of the other external output pipe that is away from the internal pipes is connected to the harmless treatment device.

[0006] Preferably, the connection between the blind box lid and the blind box body is sealed with a seal.

[0007] Preferably, the two internal pipes are spiral pipes.

[0008] Preferably, the two internal pipes are arranged to rotate and intersect each other.

[0009] Preferably, four sets of pipe connection fitting sleeves are fixedly embedded on the side wall of the blind box body, and the two ends of the two internal pipes are respectively sleeved with the four sets of pipe connection fitting sleeves. The two external input pipes and the two external output pipes are respectively detachably sleeved on the four sets of pipe connection fitting sleeves.

[0010] Compared with existing technologies, the advantages of this invention are as follows: In this invention, both the gas under study and the control gas are introduced into the blind box device. The two sets of gas pipelines that reappear from the blind box have identical appearances, making it impossible for subjects or researchers to distinguish between the study gas and the control gas, thus completing the blinding method. Compared with traditional methods that use controls with identical appearances, the blind box device of this invention is inexpensive, convenient, simple, and highly secure. Attached Figure Description

[0011] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0012] Figure 1 This is a structural schematic diagram of the present invention;

[0013] Figure 2 A schematic diagram of the external input pipe structure provided by this utility model;

[0014] Figure 3 A schematic diagram of the internal pipe structure provided for this utility model;

[0015] Figure 4 A schematic diagram of the blind box lid structure provided by this utility model;

[0016] Figure 5 This is a partial structural schematic diagram of the present invention;

[0017] The components include: 1. blind box lid; 2. seal; 3. internal pipe; 4. external input pipe; 5. pipe connection fittings; 6. blind box body; and 7. external output pipe. Detailed Implementation

[0018] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the present utility model.

[0019] To make the above-mentioned objectives, features and advantages of this utility model more apparent and understandable, the utility model will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0020] Reference Figures 1-5This utility model provides a blind box device for completing the blinding method in clinical trials related to medical gases, including a blind box cover 1 and a blind box body 6. The blind box cover 1 is disposed on the top of the blind box body 6. The outside of the blind box body 6 is provided with two sets of external input pipes 4 and two sets of external output pipes 7. The inside of the blind box body 6 is provided with two sets of internal pipes 3. The two external input pipes 4 are respectively connected to one end of the two internal pipes 3, and the two external output pipes 7 are respectively connected to the other end of the two internal pipes 3.

[0021] The ends of the two external input pipes 4 that are away from the internal pipe 3 are respectively connected to the research gas supply equipment and the control gas supply equipment. The end of one external output pipe 7 that is away from the internal pipe 3 supplies gas to the subject, and the end of the other external output pipe 7 that is away from the internal pipe 3 is connected to the harmless treatment equipment.

[0022] The main function of the blind box body 6 and the blind box lid 1 is to conceal the internal pipes 3, preventing subjects and researchers from knowing the flow path of the gas within the blind box body 6. That is, while subjects and researchers may know the types of gas introduced into the two sets of external input pipes 4, they cannot know the types of gas output from the two sets of external output pipes 7, thus achieving a double-blind study. Overall, this invention, by setting up a blind box device, ensures that after the research gas and control gas enter the blind box, researchers and subjects cannot know the flow path of the gas, and therefore cannot confirm the types of gas flowing out of the two sets of external output pipes, thus achieving a blind study. Compared to using a control machine with the same appearance, it is inexpensive, convenient, simple, and highly safe.

[0023] The scheme was further optimized so that the appearance and color of the two sets of external output pipes 7 are consistent, thereby improving the effectiveness of the double-blind study.

[0024] like Figure 4 As shown, two sets of external input pipes 4 and two sets of external output pipes 7 are respectively set on the two opposite side walls of the blind box body 6.

[0025] The design was further optimized by sealing the connection between the blind box lid 1 and the blind box body 6 with a seal 2.

[0026] like Figure 1 As shown, the connection between the blind box lid 1 and the blind box body 6 is sealed with a seal strip 2 to prevent the blind box lid 1 from separating from the blind box body 6 later. Subjects and researchers cannot know the setting status of the internal pipe 3, which effectively ensures the blind state of the experiment.

[0027] The scheme was further optimized, with the two internal pipes 3 being spiral pipes.

[0028] The internal pipe 3 is designed in a spiral shape. During the experiment, even if one end of the internal pipe 3 is pulled, the other end of the internal pipe 3 will not change position due to the buffering effect of the spiral shape. This can effectively prevent subjects and researchers from accidentally knowing the type of flowing gas and ensure the blind state of the experiment.

[0029] The design was further optimized by setting the two internal pipes 3 to rotate and intersect each other.

[0030] like Figure 3 As shown, the two sets of internal pipes 3 rotate in an intersecting manner, which can increase the complexity of the internal pipe layout and facilitate installation and fixation.

[0031] To further optimize the design, four sets of pipe connection fitting sleeves 5 are fixedly embedded on the side wall of the blind box body 6. The two ends of the two internal pipes 3 are respectively connected to the four sets of pipe connection fitting sleeves 5, and the two external input pipes 4 and the two external output pipes 7 are respectively detachably connected to the four sets of pipe connection fitting sleeves 5.

[0032] like Figure 4 As shown, two sets of pipe connection fittings 5 ​​on one side wall of the blind box body 6 are marked as inlet a and inlet b, respectively. Two sets of external input pipes 4 are connected to one end of the two internal pipes 3 through inlet a and inlet b, respectively. Two sets of pipe connection fittings 5 ​​on the other side wall of the blind box body 6 are marked as container outlet A and container outlet B, respectively. Two sets of external output pipes 7 are connected to the other end of the two internal pipes 3 through container outlet A and container outlet B, respectively.

[0033] The working process of this embodiment is as follows:

[0034] 1. Preparation Phase: First, researchers prepare the necessary research and control gases according to the experimental requirements. These gases can be oxygen, hydrogen-oxygen gas, nitrogen, carbon dioxide, etc. In this embodiment, taking the "exploratory clinical study of hydrogen-oxygen mixed gas inhalation as an adjunct therapy for coronary heart disease" as an example, the research gas is a hydrogen-oxygen mixed gas, and the control gas is oxygen.

[0035] Before the experiment, the experiment designer set inlet a and inlet b to connect to a mixture of hydrogen and oxygen or oxygen, and simultaneously set the direction of the intersecting internal pipes 3 in the blind box body 6. After the blind box was sealed, it was handed over to the experimenters to conduct clinical trials according to the experimental groups and procedures. The experiment designer did not participate in the experimental process. That is, apart from the experiment designer, no one knew the types of gas in the two output pipes of the blind box.

[0036] Based on the sample size, the trial included a total of 60 participants. The participants were divided into two groups: a hydrogen-oxygen mixed gas group and an oxygen group. Each participant used a separate blind box device for the trial, and the blind box devices were reusable.

[0037] 2. Gas introduction: According to the pre-test settings, the two sets of gases are introduced into the blind box 6 through inlet a and inlet b respectively, and then enter the two sets of internal pipes 3 respectively.

[0038] 3. Internal gas flow: The introduced gas flows through two sets of intersecting rotating internal pipes 3 inside the blind box 6.

[0039] 4. Gas Output: According to the experimental design, two sets of gases were introduced into external output pipes 7 through outlet A and outlet B, respectively. One set of gases from external output pipes 7 was directed to the subjects, while the other set was directed to a harmless treatment device for further treatment before being released. Since the two sets of external output pipes 7 appeared identical, neither the subjects nor the researchers could distinguish between the research gas and the control gas being supplied to the subjects, thus achieving a double-blind effect.

[0040] 5. Use and observation: Researchers observe and record the subjects to evaluate the treatment effect.

[0041] 6. Repeat steps 2-5 above to conduct a double-blind clinical trial for each subject.

[0042] 7. Unblinding: After all experiments are completed, the experiment designers will reveal the path of the internal pipe 3 of the blind box to the researchers and subjects, that is, reveal the types of gas in the two external output pipes 7, that is, the specific experimental group of each subject. Then, the experimental data will be further statistically analyzed according to the group.

[0043] The working principle of this invention is based on the principles of double-blind experiments and the physics of gas flow. Double-blind experiments are a commonly used scientific research method that reduces subjective bias and error by keeping both researchers and subjects unaware of the allocation of experimental and control factors.

[0044] In the description of this utility model, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0045] The embodiments described above are merely preferred embodiments of the present utility model and are not intended to limit the scope of the present utility model. Various modifications and improvements made to the technical solutions of the present utility model by those skilled in the art without departing from the spirit of the present utility model should fall within the protection scope defined by the claims of the present utility model.

Claims

1. A blind box device used in clinical trials related to medical gases to complete the blinding process, comprising a blind box lid (1) and a blind box body (6), characterized in that: The blind box lid (1) is located above the blind box body (6). The blind box body (6) has two sets of external input pipes (4) and two sets of external output pipes (7) on its exterior. The blind box body (6) has two sets of internal pipes (3) inside its interior. The two external input pipes (4) are connected to one end of the two internal pipes (3), and the two external output pipes (7) are connected to the other end of the two internal pipes (3). The ends of the two external input pipes (4) away from the internal pipe (3) are respectively connected to the research gas supply device and the control gas supply device. The end of one external output pipe (7) away from the internal pipe (3) supplies gas to the subject, and the end of the other external output pipe (7) away from the internal pipe (3) is connected to the harmless treatment device.

2. The blind box device used to complete the blinding process in clinical trials related to medical gases according to claim 1, characterized in that: The connection between the blind box lid (1) and the blind box body (6) is sealed by a seal (2).

3. The blind box device used to complete the blinding process in clinical trials related to medical gases according to claim 1, characterized in that: The two internal pipes (3) are spiral pipes.

4. The blind box device used to complete the blinding process in clinical trials related to medical gases according to claim 3, characterized in that: The two internal pipes (3) are arranged to rotate and intersect each other.

5. The blind box device used to complete the blinding process in clinical trials related to medical gases according to claim 2, characterized in that: Four sets of pipe connection fitting sleeves (5) are fixedly embedded on the side wall of the blind box body (6). The two ends of the two internal pipes (3) are respectively connected to the four sets of pipe connection fitting sleeves (5). The two external input pipes (4) and the two external output pipes (7) are respectively detachably connected to the four sets of pipe connection fitting sleeves (5).

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