Effect of Prolonged Slow Expiration Technique on Blood Gases Among Pneumatic Neonates

Pneumonia Clinical Trial

Official title:

Effect of Prolonged Slow Expiration Technique on Blood Gases Among Neonates With Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05781464
• Other study ID #: NoP.T.REC/012/003676
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: November 17, 2023

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pneumonia is a medical condition that, if not treated promptly, can lead to life- threatening complications. The prolonged slow expiration technique is a new type of chest physiotherapy that helps infants discharge bronchial secretions which accumulated due to pneumonia.

Description:

Pneumonia is an infective lung condition that is one of the most common risk factors for neonatal death. Pulmonary infections, most common caused by anaerobic bacterial infection, result in the accumulation of pus in the pleural cavity. Preterms, neonates with respiratory infections, and underdeveloped lungs all require the use of a prolonged slow expiration technique. Prolonged slow expiration technique is the only chest clearance technique that provides both effective clearance and a soothing effect. Another recommendation for this technique is lack of application of emerging techniques of respiratory physiotherapy. Although the technique is effective, it is rarely in practice over the conventional methods of chest physiotherapy. During prolonged slow expiration, intrathoracic pressure gradually rises due to thoracoabdominal compression, preventing bronchial collapse and flow disruption that occurs during forced expirations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 17, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 2 Months

Eligibility

Inclusion Criteria:

• Age since birth till 2 months
• Clinical findings of pneumonia: tachypnea, chest recession, fever, cyanosis and cough
• Radiological diagnosis of pneumonia (x-ray): lober or segmental consolidation, nodular or coarse patchy infiltration, diffuse haziness and air bronchogram.
• Neonates on oxygen therapy.

Exclusion Criteria:

• Neonates with congenital cardiopathy.
• Neonates with surgical incision in thorax or abdomen.
• Neonates with neurological intervention.
• Neonates with obstruction of upper air way.
• Neonates with gastroesophageal reflux and laryngeal affection.

Related Conditions & MeSH terms

• Pneumonia

Intervention

Procedure:
• Traditional chest physiotherapy
Postural drainage: the patient is positioned in postural drainage so that gravity had the maximum effect on the lung segment that needed to be drained, all lung zones are emphasised in positional initiatives for babies. Percussion is the rhythmic striking of the chest wall with cupped hands for 1 to 2 minutes at a time. Vibration is performed by placing fingers on the chest wall over the segment being drained and isometrically contracting the forearm and hand muscles to produce a vibratory motion. Vibration is accomplished either through manual vibratory motion of the therapist's fingers on the infant's chest wall or through the use of a mechanical vibrator ( Foreo vibrator).
• Prolonged slow expiration technique
The therapist places one hand on the thorax below the suprasternal notch and the other hand over the upper abdomen while the neonate is supine. Both hands will have hypothenar contact with the thorax and abdomen. At the end of the expiratory phase, the therapist places a compression force with both hands. Compression at the end of expiration with hypothenar eminence is kept for 2 or 3 breathing cycles. This technique is repeated several times, with a rest time between applications of about 5 or 10 spontaneous breaths.

Locations

Country	Name	City	State
Egypt	Faculty of physical Therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Gomes EL, Postiaux G, Medeiros DR, Monteiro KK, Sampaio LM, Costa D. Chest physical therapy is effective in reducing the clinical score in bronchiolitis: randomized controlled trial. Rev Bras Fisioter. 2012 Jun;16(3):241-7. doi: 10.1590/s1413-35552012005000018. Epub 2012 Apr 12. — View Citation

Lievens L, Vandenplas Y, Vanlaethem S, Van Ginderdeuren F. Prolonged Slow Expiration Technique and Gastroesophageal Reflux in Infants Under the Age of 1 Year. Front Pediatr. 2021 Sep 8;9:722452. doi: 10.3389/fped.2021.722452. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in arterial oxygen saturation (Sao2)	Arterial oxygen saturation is assessed by standardized international monitor and measured by %	Change from Baseline SaO2 at 9 days
Primary	Change in systolic and diastolic blood pressure	Systolic and diastolic blood pressure are assessed by standardized international monitor and measured by millimeters of mercury ( mmHg)	Change from baseline systolic and diastolic blood pressure at 9 days
Primary	Change in heart rate (HR)	Heart rate is assessed by standardized international monitor and measured by beats per minute (BPM)	Change from baseline HR at 9 days
Primary	Change in temperature	Temperature is assessed by thermometer and measured by degree(°)	Change from baseline temperature at 9 days
Primary	Change in power of hydrogen (PH)	PH is assessed by blood gases machine and it is a scale used to specify the acidity or basicity of blood	Change from baseline PH at 9 days
Primary	Change in partial pressure of carbon dioxide (PaCO2)	PaCO2 is assessed by blood gases machine and measured by mmHg and it serves as a marker of sufficient alveolar ventilation within the lungs	Change from baseline PaCO2 at 9 days
Primary	Change in bicarbonate (HCO3)	HCO3 is assessed by blood gases machine and measured by milliequivalents per litre (mEq/L) and it is used to detect electrolyte imbalance	Change from baseline HCO3 at 9 days