Pulmonary complications are common after abdominal surgery. Upper abdominal surgery alters postoperative pulmonary function, as observed by impairment of lung volumes such as total lung capacity, vital capacity and tidal volume. It also reduces the efficiency of efforts to cough for as long as one week. There are also falls in oxygen arterial pressure and oxygen hemoglobin saturation. The aim of the present study is to evaluate the effectiveness of deep breathing exercises (DBE) on oxygenation after major abdominal surgery.
In a prospective, randomized trial, patients performing deep-breathing exercises (n = 20) will be compared to a control group (n = 20) who perform no deep breathing exercises postoperatively. Patient management is similar in the groups in terms of assessment, positioning, and mobility.
Pulse oximetry, respiratory rate (RR), heart rate (HR), and mean arterial pressure (MAP) will be recorded. A visual pain scale will be applied before and after DBE.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011012560N5
Registration date:2010-12-02, 1389/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-02, 1389/09/11
Registrant information
Name
Mohammad reza Yeganehkhah
Name of organization / entity
Qom University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6630 4368
Email address
yeganehkhah@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Qom University of Medical Sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of deep breathing exercises on oxygenation of patients undergoing major abdominal surgery
Public title
Effect of deep breathing exercises on oxygenation of patients undergoing major abdominal surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1) Patients who undergoing elective major abdominal surgery. 2) Having complete alert and ability of patient to performing deep-breathing exercises. 3) Having no history of surgery. 4) Patients undergoing general anesthesia. 5) Not to use pulmonary drugs. Exclusive criteria: 1) Patients with active pulmonary pathology (COPD and Asthma), CHF, CRF and unstable cardiovascular condition. 2) active pulmonary and cardiac pathology (eg, ARDS and unstable angina). 3) Patients with an indication for liver transplantation, or who presented aneurysm of any arterial segment. 4) Patients with active bleeding after surgery and who needed to operating room or who transferred to intensive care unit. 5) Patients with pulmonary aspiration and temperature over 38° c.
Age
No age limit
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
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
Qom University of Medical Sciences and Health Services
Street address
Saheli st.
City
Qom
Postal code
Approval date
2010-10-21, 1389/07/29
Ethics committee reference number
ت/12050/34
Health conditions studied
1
Description of health condition studied
Acute pulmonary insufficiency following obdoman surgery
ICD-10 code
J95.2
ICD-10 code description
Acute pulmonary insufficiency following nonthoracic surgery
Primary outcomes
1
Description
SpO2
Timepoint
before surgery and before and immediately after deep breathing exercise
Method of measurement
Pulse oximetry
2
Description
Heart rate
Timepoint
Before surgery and before and immediately after deep breathing exercise
Method of measurement
monitoring equipment
3
Description
respiratory rate
Timepoint
Before surgery and before and immediately after deep breathing exercise
Method of measurement
monitoring equipment
4
Description
mean arterial pressure
Timepoint
Before surgery and before and immediately after deep breathing exercise
Method of measurement
monitoring equipment
5
Description
Pain
Timepoint
Before deep breathing exercise
Method of measurement
visual pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group: The patients in the experimental group will be informed and practiced the breathing technique preoperatively. Deep breathing exercise (DBE) will be initiated approximately 2 hours after surgery when patients awake (in daytime). While resting in a semi-recumbent position, the patients will be instructed to inhale as slowly and deeply as possible, hold their breath for 3 seconds, and then exhale in a relaxed manner while coughing during it. With the help of a researcher nurse using proprioceptive input, the patients will be encouraged to make each subsequent breath deeper than the previous breath for 10 breaths. After 10 breaths, the patients will perform incentive spirometry by latex glove for 2 minute. These periods will be followed by a rest period (ie, normal breathing), and the cycle will be repeated four times per hour for 2 consecutive hours.
Category
Other
2
Description
Control group: Patients in the control group receive routine care by the nurses. They don't receive any deep breathing exercise (DBE).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid- Beheshti hospital
Full name of responsible person
Street address
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences and Health Services
Full name of responsible person
Ali Salimi
Street address
Saheli st.
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences and Health Services