- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07579013
Effect of Postural Drainage With or Without Thoracic Squeezing on O2 and Respiratory Rate in Infant With RDS.
Immediate Effects of Postural Drainage With or Without Thoracic Squeezing on Oxygen Saturation and Respiratory Rate in Children With Respiratory Distress Syndrome.
This study investigated whether adding thoracic squeezing to postural drainage improves immediate respiratory outcomes in preterm infants with Respiratory Distress Syndrome (RDS).
Over nine months, 14 preterm infants (all born via cesarean section) were randomly assigned to two groups. The control group received standard care with postural drainage, while the experimental group received postural drainage combined with the lung squeezing technique (LST), which applies gentle chest pressure to enhance airflow and mucus clearance. Infants with genetic disorders, congenital anomalies, or on neurotropic drugs were excluded.
Oxygen saturation and respiratory distress were measured using the Oxygen Saturation Index and Silverman-Anderson Scale, with data analyzed in SPSS.
The study aimed to determine whether combining thoracic squeezing with postural drainage has a greater immediate effect on improving oxygen levels and reducing respiratory distress compared to postural drainage alone.
연구 개요
상세 설명
Respiratory distress syndrome (RDS) is a common respiratory condition affecting preterm infants, characterized by insufficient lung function leading to impaired oxygenation and increased respiratory effort. Physiotherapy interventions like postural drainage are often used to improve lung clearance and respiratory status. However, the effectiveness of combining postural drainage with thoracic squeezing on immediate respiratory outcomes remains unclear. The lung squeezing technique (LST), an advanced form of chest physiotherapy, involves applying gentle, sustained pressure to the chest wall, followed by a full release. This process helps elevate intrathoracic pressure, which can activate the cough reflex, aid in the movement of mucus, promote deeper inhalation, and enhance ventilation within the alveoli. The objective of the study is aimed to evaluate the immediate effects of postural drainage with or without thoracic squeezing on oxygen saturation and respiratory rate in children with RDS.
This study was conducted over nine months at AMTH and HLTH settings, enrolling a total of 14 preterm infants with a history of cesarean section birth. Participants were selected using the Epi tool for sample size calculation and randomized into two groups: the control group received standard care involving postural training, while the experimental group underwent postural drainage combined with thoracic squeezing techniques. Exclusion criteria included infants under treatment with neurotropic drugs, those diagnosed with genetic disorders, and those presenting with congenital cardiac or respiratory anomalies. Data collection employed the Oxygen Saturation Index to measure oxygen levels and the Silverman-Anderson Scale to assess respiratory distress. Collected data were analyzed using SPSS software to determine the effects of the interventions on oxygen saturation and respiratory rate.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: IMRAN AMJAD, PHD
- 전화번호: +9233224390125
- 이메일: imran.amjad@riphah.edu.pk
연구 연락처 백업
- 이름: Muhammad Asif Javed, PhD*
- 전화번호: +923224209422
- 이메일: a.javed@riphah.edu.pk
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄, 54000
- 모병
- Children Hospital
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연락하다:
- IMRAN AMJAD, PHD
- 전화번호: +9233224390125
- 이메일: imran.amjad@riphah.edu.pk
-
연락하다:
- MUHAMMAD ASIF JAVED, MS-PT
- 전화번호: +923224209422
- 이메일: a.javed@riphah.edu.pk
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
● Children diagnosed with RDS.
- Pre term infants. Birth history with c- section.
- No congenital malformation.
Exclusion Criteria:
● Under treatment with neurotropic drugs.
- Respiratory and cardiac congenital anamolies.
- Genetic disorder.
- Interventricular hemorrhage or seizures.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Oxygenation levels
Evaluated using measures such as pulse oxygen saturation (SpO2) or arterial oxygen saturation (SaO2), arterial partial pressure of oxygen (PaO2), or the Oxygen Saturation Index (OSI). This calculation provides a non-invasive measure of oxygenation efficiency. Research has shown that OSI is just as reliable as the Oxygenation Index (OI) in evaluating the severity of pediatric acute respiratory distress syndrome (PARDS). Since OSI uses peripheral oxygen saturation (SpO₂) instead of arterial blood gases, it serves as a practical and effective alternative, particularly in settings where frequent arterial sampling is not feasible. The Oxygen Saturation Index (OSI) is determined using the formula: (FiO₂ × mean airway pressure × 100) ÷ SpO₂ (14). |
A structured chest physiotherapy protocol will be applied in neonates to enhance airway clearance by targeting specific lung segments.
This includes appropriate positioning-supine for upper lobes and side-lying for lower lobes-combined with gentle chest percussion to mobilize secretions while avoiding sensitive areas.
Sessions last 4-5 minutes and are repeated every 3 hours, with careful monitoring of vital signs and precautions such as avoiding treatment soon after feeding.
Additionally, the thoracic squeezing technique is used to simulate a cough by applying gentle, rhythmic compressions during expiration in a side-lying position.
Performed for about 10 minutes on each side after drainage or percussion, it helps move secretions toward central airways, particularly in infants with weak cough reflexes, with continuous monitoring to ensure safety and immediate cessation if distress occurs.
다른 이름들:
|
|
실험적: ANDERSON Scale.
The Silverman-Anderson scores are widely used clinical tools designed to evaluate the severity of respiratory distress in newborns.
Both systems rely on objective clinical parameters to quantify respiratory difficulty.
The Silverman-Anderson score specifically measures five key signs: chest retractions in the upper and lower thorax, subxiphoid retraction, nasal flaring, and audible grunting during exhalation.
Each of these indicators is rated on a scale from 0 to 2, allowing healthcare providers to systematically assess and monitor the progression or improvement of respiratory distress in neonates.
|
A structured chest physiotherapy protocol will be applied in neonates to enhance airway clearance by targeting specific lung segments.
This includes appropriate positioning-supine for upper lobes and side-lying for lower lobes-combined with gentle chest percussion to mobilize secretions while avoiding sensitive areas.
Sessions last 4-5 minutes and are repeated every 3 hours, with careful monitoring of vital signs and precautions such as avoiding treatment soon after feeding.
Additionally, the thoracic squeezing technique is used to simulate a cough by applying gentle, rhythmic compressions during expiration in a side-lying position.
Performed for about 10 minutes on each side after drainage or percussion, it helps move secretions toward central airways, particularly in infants with weak cough reflexes, with continuous monitoring to ensure safety and immediate cessation if distress occurs.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Oxygenation levels
기간: BASE LINE, 4 WEEKS
|
Evaluated using measures such as pulse oxygen saturation (SpO2) or arterial oxygen saturation (SaO2), arterial partial pressure of oxygen (PaO2), or the Oxygen Saturation Index (OSI). This calculation provides a non-invasive measure of oxygenation efficiency. Research has shown that OSI is just as reliable as the Oxygenation Index (OI) in evaluating the severity of pediatric acute respiratory distress syndrome (PARDS). Since OSI uses peripheral oxygen saturation (SpO₂) instead of arterial blood gases, it serves as a practical and effective alternative, particularly in settings where frequent arterial sampling is not feasible. The Oxygen Saturation Index (OSI) is determined using the formula: (FiO₂ × mean airway pressure × 100) ÷ SpO₂ (14). |
BASE LINE, 4 WEEKS
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
ANDERSON Scale
기간: BASE LINE, 4 WEEKS
|
The Silverman-Anderson scores are widely used clinical tools designed to evaluate the severity of respiratory distress in newborns.
Both systems rely on objective clinical parameters to quantify respiratory difficulty.
The Silverman-Anderson score specifically measures five key signs: chest retractions in the upper and lower thorax, subxiphoid retraction, nasal flaring, and audible grunting during exhalation.
Each of these indicators is rated on a scale from 0 to 2, allowing healthcare providers to systematically assess and monitor the progression or improvement of respiratory distress in neonates.
|
BASE LINE, 4 WEEKS
|
공동 작업자 및 조사자
수사관
- 수석 연구원: NIMRA MUBASHAR, MS-PT, Riphah International University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 연구와 관련된 용어
기타 연구 ID 번호
- REC/RCR&AHS/NIMRA
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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