- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: IMRAN AMJAD, PHD
- Telefonnummer: +9233224390125
- E-mail: imran.amjad@riphah.edu.pk
Undersøgelse Kontakt Backup
- Navn: Muhammad Asif Javed, PhD*
- Telefonnummer: +923224209422
- E-mail: a.javed@riphah.edu.pk
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Rekruttering
- Children Hospital
-
Kontakt:
- IMRAN AMJAD, PHD
- Telefonnummer: +9233224390125
- E-mail: imran.amjad@riphah.edu.pk
-
Kontakt:
- MUHAMMAD ASIF JAVED, MS-PT
- Telefonnummer: +923224209422
- E-mail: a.javed@riphah.edu.pk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Oxygenation levels
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
ANDERSON Scale
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: NIMRA MUBASHAR, MS-PT, Riphah International University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REC/RCR&AHS/NIMRA
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Respiratory Distress Syndrome
-
PT. Prodia Stem Cell IndonesiaRumah Sakit Pusat Angkatan Darat Gatot SoebrotoRekrutteringAcute respiratory distress syndromIndonesien
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Ikke rekrutterer endnu
-
Changchun Tuohua Pharmaceutical Co., Ltd.RekrutteringAcute respiratory distress syndromKina
-
Southeast University, ChinaRekrutteringAcute respiratory distress syndromKina
-
Southeast University, ChinaRekrutteringAcute respiratory distress syndromKina
-
Assiut UniversityIkke rekrutterer endnuAcute respiratory distress syndrom
-
Breathe Biologics, Inc.Ikke rekrutterer endnu
-
Wu RongzhouAfsluttetAcute respiratory distress syndrom | Lungebetændelse hos børn | Åndedrætssvigt (pædiatriske patienter)Kina
-
Centre Hospitalier Universitaire, AmiensIkke rekrutterer endnuAcute respiratory distress syndrom | Ventilator-induceret lungeskade | Højde | Tidevandsvolumen | Forventet kropsvægtFrankrig
-
Union Hospital, Tongji Medical College, Huazhong...Ikke rekrutterer endnuStød | Acute respiratory distress syndromKina
Kliniske forsøg med POSTURAL DRAINAGE TECHNIQUE
-
Riphah International UniversityRekrutteringKronisk obstruktiv lungesygdomPakistan
-
Riphah International UniversityAfsluttetKronisk lungesygdomPakistan
-
Universidad Complutense de MadridSociedad Española de Neumología y Cirugía TorácicaAfsluttetBarn | Neurologisk lidelse | Respiratorisk komplikation
-
Riphah International UniversityAfsluttet
-
Changhai HospitalPeking Union Medical College Hospital; Beijing Tiantan Hospital; Huashan... og andre samarbejdspartnereRekrutteringMavekræft | SpiserørskræftKina
-
Lincoln University CollegeAfsluttetFremadrettet hovedstilling | Thorakal hyperkyfoseSaudi Arabien
-
University of Sao PauloAfsluttet
-
Riphah International UniversityRekrutteringProlaps af bækkenorganerPakistan
-
Riphah International UniversityAfsluttet
-
University Hospital, RouenIkke rekrutterer endnuMænd, der har gennemgået prostatektomiFrankrig