The effect of deep respiratory exercise on oxygenation of patients under major abdominal surgery

Last registered on November 14, 2013

Pre-Trial

Trial Information

General Information

Title
The effect of deep respiratory exercise on oxygenation of patients under major abdominal surgery
RCT ID
AEARCTR-0000113
First published
November 14, 2013, 7:42 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Primary Investigator

Affiliation

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2012-05-01
End date
2013-05-31
Secondary IDs
Abstract
Background and Purpose: Millions of people around the world experience abdominal surgery every year. Despite of subsequent advances in anesthesia and surgical care, postoperative pulmonary complications (PPCs) still are a significant problem in modern practice.
This study was done to investigate the effect of deep respiratory effect on oxygenation of patient under major abdominal surgery.

Design: In this single-blind randomized clinical trial which was done in surgery ward of Shahid Beheshti Hospital in QOM in 2012, forty elective patients who needed major
abdominal surgery participated in this study and were divided to two equal groups(control and experimental). Control group had been received routine care but experimental
group in addition of ordinary care, repeated deep respiratory exercise four times an hour for 2 consecutive hours. The arrangement of patients about their position, mobility
and oxygen therapy were the same. Oxygen saturation, respiratory rate, heart rate, mean blood pressure and the severity of pain in surgery site were measured before and
after intervention. Chi-square test, Fischer exact test, t-test, Paired t- test, Wilcoxon rank sum test, Kolmogorov-Smirnov test, loan test and Manvitini test were used for data
analyzing.
Findings: Before intervention, two groups had no significant difference about demographic characteristics, intermediary factors in oxygenation, the severity of pain in surgery
site, pulse rate, mean artery blood pressure, respiratory rate ,and O2 saturation(P>0.05).After the intervention, the change of O2 saturation and the severity of pain in surgery
site were significant (P<0.05).Furthermore the results revealed, the deep respiratory exercise can reduce the pain of surgery site and mean blood pressure and increase the
O2 saturation in experimental group.
Conclusion: Deep respiratory exercise can reduce the severity of pain in surgery site and mean artery blood pressure and increase the O2 saturation in patients after major abdominal surgery
External Link(s)

Registration Citation

Citation
Jangholi, Ehsan. 2013. "The effect of deep respiratory exercise on oxygenation of patients under major abdominal surgery." AEA RCT Registry. November 14. https://doi.org/10.1257/rct.113-1.0
Former Citation
Jangholi, Ehsan. 2013. "The effect of deep respiratory exercise on oxygenation of patients under major abdominal surgery." AEA RCT Registry. November 14. https://www.socialscienceregistry.org/trials/113/history/512
Experimental Details

Interventions

Intervention(s)
Intervention in experimental group was in such a way that the patients of this group two hours after surgery and consciousness ,in semi sitting position encouraged to respire deeply and gently ,then keep it for 3 number and after that expirate gentle via mouth. During the expiration they should cough 2 times efficiently (during coughing it was educated to patients to keep incision of surgery with pillow).
The researcher encouraged the patients to breathe 10 times deeper and deeper. After that they were encouraged to do motivational spirometery for 2 minutes (by using latex gloves without powder).
The above circle repeated 4 times each hour for 2 consecutive hours. After and before 8 sessions of deep respiratory exercises, the hemodynamic symptoms including: heart rate and blood pressure, respiratory parameters including: respiratory rate and Oxygen saturation (SpO2) and the severity of pain in surgery site were measured by noninvolved nurse in this study.
Intervention Start Date
2012-05-31
Intervention End Date
2013-05-01

Primary Outcomes

Primary Outcomes (end points)
Oxygen saturation
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The participants according to altered randomized blocks were divided to experimental (n=20) and control (n=20) groups. For prevention of any relation between two groups, the patients of each group were hospitalized in separate wards. The day before surgery ,the practical education of deep respiratory exercise was trained to experimental group and wanted them to repeat these exercise several times to make sure the researcher about understanding them.
Intervention in experimental group was in such a way that the patients of this group two hours after surgery and consciousness ,in semi sitting position encouraged to respire deeply and gently ,then keep it for 3 number and after that expirate gentle via mouth. During the expiration they should cough 2 times efficiently (during coughing it was educated to patients to keep incision of surgery with pillow).
The researcher encouraged the patients to breathe 10 times deeper and deeper. After that they were encouraged to do motivational spirometery for 2 minutes (by using latex gloves without powder).
The above circle repeated 4 times each hour for 2 consecutive hours. After and before 8 sessions of deep respiratory exercises, the hemodynamic symptoms including: heart rate and blood pressure, respiratory parameters including: respiratory rate and Oxygen saturation (SpO2) and the severity of pain in surgery site were measured by noninvolved nurse in this study.
In control group, except routine care, the deep respiratory exercise schedule was not done. The respiratory symptoms, the severity of surgery site pain and hemodynamic symptoms before and after 2 hours were measured by the same nurse.
The arrangement of patients about their mobility, position, oxygen intake and measurement devices were the same.
The blood pressure according to The Seventh Report of the Joint National Committee on Prevention Detection, valuation, and Treatment of High Blood Pressure instruction, was measured by mercurial manometer and stethoscope in semi sitting position after 3 minutes of resting.
Mercurial manometer and stethoscope of Richter brand after consultation with medical experts was prepared and its stability was proved after retest with another standard device and calculation of Pierson stability factor of these 2 measurements (rdiastol=0.90, rsystol=0.93).
Abadis BC pulse oxymeter which was calibrated newly was used in this study. All of interference factors in SPO2 measurement including: the right position of sensor, the same finger in all patients, non-visible anomaly in nail bed, uncovered of nail bed and indirect radiation to sensor were under control.
Experimental Design Details
Randomization Method
Public lottery
Randomization Unit
blocks
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
60
Sample size: planned number of observations
40
Sample size (or number of clusters) by treatment arms
20
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
ethic committee of medical science university of Qom
IRB Approval Date
2012-04-12
IRB Approval Number
1137646111

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
May 01, 2013, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
May 31, 2013, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
40
Was attrition correlated with treatment status?
Yes
Final Sample Size: Total Number of Observations
40
Final Sample Size (or Number of Clusters) by Treatment Arms
20
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials