To Comparing Impacts of Prone and Semi-sitting Positions on Cardiac and Respiratory Indices among Patients with Chronic Obstructive Pulmonary Disease
Design
Two arm parallel group randomized trial
Settings and conduct
The research population includes all COPD outpatients who referred to Peymanieh Hospital’s clinic in Jahrom and met the inclusion criteria.
Participants/Inclusion and exclusion criteria
• Suffering from chronic obstructive pulmonary disease (COPD)
• Being 18-60 years old
• Being able to perform the intervention
• Not having pressure ulcers on the shoulders, knees and face
• Not having symptoms of increased intracranial pressure
• Having no contraindications for the prone position, e.g., severe obesity, hemodynamic instability, unstable pelvic/long bone fractures, open abdominal wounds and increased intracranial pressure
Intervention groups
Patients will be taught that the head is rotated to the side and arms are positioned parallel to the body in the prone position. A towel roll is placed under the upper chest wall and a pillow is placed under the pelvis to minimize abdominal movement. Each patient will remain in this position once a day for one hour over five consecutive days at home.
Main outcome variables
HR, SBP/DBP, pao2, pco2, o2sat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230730058966N1
Registration date:2024-11-14, 1403/08/24
Registration timing:registered_while_recruiting
Last update:2024-11-14, 1403/08/24
Update count:0
Registration date
2024-11-14, 1403/08/24
Registrant information
Name
mahdi karimyar jahromi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5422 1520
Email address
mahdikarimyar310@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-05, 1403/08/15
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Impacts of Prone and Semi-sitting Positions on Cardiac and Respiratory Indices among Patients with Chronic Obstructive Pulmonary Disease
Public title
Impacts of Prone and Semi-sitting Positions on Cardiac and Respiratory Indices among COPD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from chronic obstructive pulmonary disease (COPD)
Being able to perform the intervention
Not having pressure ulcers on the shoulders, knees and face
Not having symptoms of increased intracranial pressure
Having no contraindications for the prone position, e.g., severe obesity, hemodynamic instability, unstable pelvic/long bone fractures, open abdominal wounds and increased intracranial pressure
Exclusion criteria:
Suffering from mental or cognitive disorders
Having progressive neuromuscular disorders
Having decreased level of consciousness
Having unstable fractures
Having deep vein thrombosis (to minimize the risk of pulmonary embolism in the prone position)
Having mean arterial pressure below 65 mmHg with or without taking vasopressors
Undergoing tracheal surgery or sternotomy within the past 15 days
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will randomly divided into two experimental and control groups with random number table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Jahrom University of Medical Sciences
Street address
Office of Research & Technology Main Campus of Jahrom University of Medical Sciences, Motahari Blvd, Jahrom