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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05781464
Collaborator
(none)
32
2
10

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Traditional chest physiotherapy
  • Procedure: Prolonged slow expiration technique
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Prolonged Slow Expiration Technique on Blood Gases Among Neonates With Pneumonia
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Traditional chest physiotherapy

This group receives traditional chest physiotherapy that include postural drainage, percussion and vibration ( manually or by a vibrator) in each session which is twice daily from admission to neonatal intensive care unit till discharge

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).
Other Names:
  • Postural drainage
  • Percussion
  • Vibration
  • Foreo Vibrator
  • Active Comparator: Prolonged slow expiration technique and traditional chest physiotherapy

    This group receives traditional chest physiotherapy that include postural drainage, percussion and vibration ( manually or by a vibrator) plus prolonged slow expiration technique in each session which is twice daily from admission in neonatal intensive care unit till discharge.

    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).
    Other Names:
  • Postural drainage
  • Percussion
  • Vibration
  • Foreo Vibrator
  • Procedure: 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in arterial oxygen saturation (Sao2) [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 [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) [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 [Change from baseline temperature at 9 days]

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

    5. Change in power of hydrogen (PH) [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) [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) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 2 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Chair: Elham El hadedy, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Moshira Mohamed Metwally, Physical therapist, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05781464
    Other Study ID Numbers:
    • NoP.T.REC/012/003676
    First Posted:
    Mar 23, 2023
    Last Update Posted:
    Mar 23, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 23, 2023