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The primary objective of the study will be to determine whether rapid remote limb ischemic preconditioning (RIPC) combined with acetazolamide can further reduce the incidence of acute mountain sickness (AMS) during the 6-hour hypoxic chamber.
The current measures to prevent acute mountain sickness (AMS) mainly include drug prevention and non-drug prevention. Acetazolamide is a drug approved by the U.S. FDA for the prevention and treatment of AMS. Remote limb ischemic preconditioning (RIPC) can also reduce the incidence of AMS as a non-durg method, with a strategy of 2 times/day training for 1 week reducing the incidence of AMS in 6 hours from 40% to 30%. The objective of this study is to determine whether rapid RIPC training combined with acetazolamide can further reduce the incidence of AMS. In this study, subjects will be divided into 5 groups: medicine group (acetazolamid 125mg bid, 2 days before entering the hypoxic room), RIPC group (RIPC training twice daily, 6 days before entering the hypoxic room), rapid RIPC group (RIPC training forth daily, 3 days before entering the hypoxic room), combined group (rapid RIPC training plus acetazolamide) and controlled group. RIPC training, completed by Renqiao Remote Ischemic Conditioning Device (Doctormate®), will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. After the intervention, subjects will be exposed to 4500m altitude in a normobaric hypoxic chamber for 6 hours. The incidence of AMS and other data will be compared between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medicine Group | Active Comparator | Start orally take Acetazolamide 2 days before entering the hypoxic room. |
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| RIPC Group | Active Comparator | Start RIPC training twice daily, 6 days before entering the hypoxic room. |
|
| Rapid RIPC Group | Experimental | Start RIPC training forth daily, 3 days before entering the hypoxic room. |
|
| Combined Group | Experimental | Medicine + Rapid RIPC |
|
| Control Group | No Intervention | Subjects do not receive specific interventions before entering the hypoxic room. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | Start orally take acetazolamide 125mg twice daily, 2 days before entering the hypoxic chamber. Subjects will enter the hypoxic room at 9am on the third day. At that time, the subject should have taken the drug 5 times. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of acute mountain sickness. | The diagnosis of acute mountain sickness is based on '2018 Lake Louise Acute Mountain Sickness Score' , 'Acute Mountain Sickness-Cerebral Scores',etc. All subjects should finish the questionnaires to evaluate the total incidence. | 6 hours after entering the hypoxic room. |
| The severity of acute mountain sickness. | The diagnosis of acute mountain sickness is based on '2018 Lake Louise Acute Mountain Sickness Score' , 'Acute Mountain Sickness-Cerebral Scores',etc. All subjects should finish the questionnaires to evaluate the total incidence. | 6 hours after entering the hypoxic room. |
| Fingre pulse oximetry of the subjects. | Fingre pulse oximetry using pocket pulse oximeters will be noted. | 6 hours after entering the hypoxic room. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure of the subjects. | Including systolic and diastolic pressure. | 6 hours after entering the hypoxic room. |
| Heart rate of the subjects. | 6 hours after entering the hypoxic room. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xunming Ji, MD.PhD | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38166913 | Derived | Liu M, Jiao X, Li R, Li J, Wang L, Wang L, Wang Y, Lv C, Huang D, Wei R, Wang L, Ji X, Guo X. Effects of acetazolamide combined with remote ischemic preconditioning on risk of acute mountain sickness: a randomized clinical trial. BMC Med. 2024 Jan 2;22(1):4. doi: 10.1186/s12916-023-03209-7. |
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| ID | Term |
|---|---|
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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Due to the nature of the procedure, it was not possible to blind subjects to the intervention of medicine or RIPC.
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| Doctormate® (twice daily for 6 days) | Device | Start RIPC training twice daily, 6 days before entering the hypoxic chamber. RIPC will be induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®). Each training will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Subjects will enter the hypoxic room at 9am on the seventh day. At that time, the subject should have finished 13 times of RIPC training. |
|
| Doctormate® (forth daily for 3 days) | Device | Start RIPC training forth daily, 3 days before entering the hypoxic chamber. RIPC will be induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®). Each training will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Subjects will enter the hypoxic room at 9am on the forth day. At that time, the subject should have finished 13 times of RIPC training. |
|
| Respiratory rate of the subjects. | 6 hours after entering the hypoxic room. |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |