- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07586345
The Effectiveness of Different Nebulized Solutions on Airway Clearance Function in Patients With Pneumonia
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Diagnosed with pneumonia, defined by ICD-10 codes, including:
J18: Pneumonia, unspecified organism J180: Bronchopneumonia, unspecified organism J181: Lobar pneumonia, unspecified organism J182: Hypostatic pneumonia, unspecified organism J188: Other pneumonia, unspecified organism J189: Pneumonia, unspecified organism
- Aged 18-100 years
- Clinical respiratory score > 3
- Patients unable to expectorate sputum spontaneously and requiring assisted suctioning
Exclusion Criteria:
Diagnosis of influenza-associated pneumonia, defined by ICD-10 codes, including:
J09X1: Influenza due to identified novel influenza A virus with pneumonia J1001: Influenza due to other identified influenza virus with the same identified influenza viral pneumonia J100: Influenza due to other identified influenza virus with pneumonia
Diagnosis of COVID-19 infection, defined by ICD-10 code:
U07.1: COVID-19, virus identified
- History of chronic obstructive pulmonary disease (COPD) (ICD-10 code: J44)
- History of lung cancer or metastatic cancer involving the lungs
- Current use of bronchodilators
- Patients requiring oral suctioning only
- Oxygen therapy with a flow rate > 10 L/min
- Clinical respiratory score > 8 (Table 2)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 대조군
|
Comparison of different concentrations of saline solutions used for nebulization therapy
|
|
활성 비교기: Hypertonic group
|
Comparison of different concentrations of saline solutions used for nebulization therapy
|
|
활성 비교기: Isotonic group
|
Comparison of different concentrations of saline solutions used for nebulization therapy
|
|
활성 비교기: Hypotonic group
|
Comparison of different concentrations of saline solutions used for nebulization therapy
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Vein blood gas
기간: Measurements were performed before the intervention and at 7 days after the intervention.
|
Assessment of venous blood gas values including pH, pCO₂, and HCO₃-.
|
Measurements were performed before the intervention and at 7 days after the intervention.
|
|
Sputum routine examination
기간: Measurements were performed before the intervention and at 7 days after the intervention.
|
Assessment of sputum characteristics and routine laboratory findings.
|
Measurements were performed before the intervention and at 7 days after the intervention.
|
|
Arterial oxygen content (CaO₂)
기간: Measurements were performed before the intervention and at 7 days after the intervention.
|
Measurement of arterial oxygen content calculated from hemoglobin concentration, oxygen saturation, and partial pressure of oxygen. Unit of Measure: mL O₂/dL blood |
Measurements were performed before the intervention and at 7 days after the intervention.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Blood lactic acid level
기간: Measurements were performed before the intervention and at 7 days after the intervention.
|
Measurement of serum lactic acid concentration.
Unit of Measure: mmol/L
|
Measurements were performed before the intervention and at 7 days after the intervention.
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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