Effects of IMT on Pulmonary Functions IN CASES With Inhalation Injury

Pulmonary Function Clinical Trial

Official title:

Effects of Inspiratory Muscle Training on Clinical Predictors of Respiratory Muscle Strength and Lung Function in Burned Patients With Inhalation Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05190497
• Other study ID #: IMT in inhalation injury
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: December 2021
• Source: Cairo University
• Contact: KHALED T AHMED, Asso Prof
• Phone: 00201115586016
• Email: khaled.takey[@]must.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study aimed to investigate the effect of inspiratory muscle training (IMT) on pulmonary functions (FEV1and FVC), and respiratory muscle strength in patients with inhalation injury, which may prove to be a promising intervention helping to improve exercise tolerance, relieve dyspnea and suggests an improvement in respiratory muscle function.

Description:

Forty male patients suffering from inhalation injury were been included in this study, Participants' ages ranged from 20-35 years old. Patients were selected from the burn department, Om El-Masreen hospital, and randomly assigned into two equal groups.

The exercise group received inspiratory muscle training in addition to routine chest physiotherapy in the form of (deep breathing, coughing, and early ambulation) three times per week for four weeks (group A). The Control group received only routine chest physiotherapy (group B). This study obtained ethical approval by the institutional review board of the Faculty of Physical Therapy - Cairo University, with reference number: P.T.REC/012/003431

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion criteria:

• Male patients suffering from inhalation injury.

• Participant age ranged from 20-35 years old.

• All patients had the same medical care.

• Participants have received a good explanation of the treatment and measurement device.

• Treatment was conducted one month after inhalation injury.

Exclusion criteria:

Patients were excluded from this study for any of the following cases such as

• Instability of patient's medical condition.

• Presence of any diseases that could affect the study results.

• Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.

Related Conditions & MeSH terms

• Inhalation Injury
• Pulmonary Function
• Respiratory Aspiration
• Respiratory Muscle Strength
• Wounds and Injuries

Intervention

Device:
• Exercise group
Maximal respiratory pressure and reflecting muscles strength were measured by a mouth pressure meter

Locations

Country	Name	City	State
Egypt	Khaled Takey Ahmed	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Gupta K, Mehrotra M, Kumar P, Gogia AR, Prasad A, Fisher JA. Smoke Inhalation Injury: Etiopathogenesis, Diagnosis, and Management. Indian J Crit Care Med. 2018 Mar;22(3):180-188. doi: 10.4103/ijccm.IJCCM_460_17. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PULMONARY FUNCTION TEST	Each patient's weight in kilograms, and height in meters were recorded and entered the machine. An individual sat in a chair and inhaled deeply before closing their mouth tightly around the tube. Several exercises were carried out until the patient comprehended and was comfortable with the instruction. The patient inhaled deeply and exhaled as quickly as possible into the spirometer(Morgan Trans Flow Test Vicatest p2 (Kent, ME 87 ED, England).	3 MONTHS
Primary	Respiratory muscles Strength Measurement	Maximal respiratory pressure and reflecting muscles strength were measured by a mouth pressure meter (Pony FX; COSMED, Rome, Italy) in the sitting position. The highest maximal expiratory pressure (MEP) in cmH2O, and maximal inspiratory pressure (MIP) in cmH2O values in three or more attempts were chosen. Investigators calculated the predicted MEP and MIP values based on age, height, and weight	3 MONTHS