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OpenTrials
Completed

NCT Number: NCT05781464

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

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.

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Key information

Age range

1 day–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical Therapy

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional chest physiotherapy

Procedure

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).

Other names: Postural drainage, Percussion, Vibration, Foreo Vibrator

Prolonged slow expiration technique

Procedure

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.

Primary outcomes

  1. Change in arterial oxygen saturation (Sao2)

    Time frame: Change from Baseline SaO2 at 9 days

    Arterial oxygen saturation is assessed by standardized international monitor and measured by %

  2. Change in systolic and diastolic blood pressure

    Time frame: Change from baseline systolic and diastolic blood pressure at 9 days

    Systolic and diastolic blood pressure are assessed by standardized international monitor and measured by millimeters of mercury ( mmHg)

  3. Change in heart rate (HR)

    Time frame: Change from baseline HR at 9 days

    Heart rate is assessed by standardized international monitor and measured by beats per minute (BPM)

  4. Change in temperature

    Time frame: Change from baseline temperature at 9 days

    Temperature is assessed by thermometer and measured by degree(°)

  5. Change in power of hydrogen (PH)

    Time frame: Change from baseline PH at 9 days

    PH is assessed by blood gases machine and it is a scale used to specify the acidity or basicity of blood

  6. Change in partial pressure of carbon dioxide (PaCO2)

    Time frame: Change from baseline PaCO2 at 9 days

    PaCO2 is assessed by blood gases machine and measured by mmHg and it serves as a marker of sufficient alveolar ventilation within the lungs

  7. Change in bicarbonate (HCO3)

    Time frame: Change from baseline HCO3 at 9 days

    HCO3 is assessed by blood gases machine and measured by milliequivalents per litre (mEq/L) and it is used to detect electrolyte imbalance

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2023
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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