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

NCT05781464 | Completed

• 1 other identifier: NoP.T.REC/012/003676
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• Change in temperature

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

  Change from baseline temperature at 9 days

• 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

• 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

• 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

Study Arms (2)

Traditional chest physiotherapy

PLACEBO COMPARATOR

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

Prolonged slow expiration technique and traditional chest physiotherapy

ACTIVE COMPARATOR

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; Procedure: Prolonged slow expiration technique

Interventions

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).

Also known as: Postural drainage, Percussion, Vibration, Foreo Vibrator

Prolonged slow expiration technique and traditional chest physiotherapy; Traditional chest physiotherapy

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.

Prolonged slow expiration technique and traditional chest physiotherapy

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical Therapy

Giza, Egypt

Location

Related Publications (2)

• 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.

  PMID: 34568241 BACKGROUND

• 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.

  PMID: 22499404 BACKGROUND

MeSH Terms

Conditions

Pneumonia

Interventions

Drainage, Postural; Vibration

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Physical Therapy Modalities; Rehabilitation; Respiratory Therapy; Mechanical Phenomena; Physical Phenomena

Study Officials

• Elham Salem

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: March 23, 2023
• Study Start: April 1, 2023
• Primary Completion: August 3, 2023
• Study Completion: November 17, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-03

Locations

EG (1)