The effect of manual lung hyperinflation on pulmonary function and incidence of atelectasis in patients undergoing abdominal surgery and T-tube support
This study is conducted for evaluating the effect of manual lung hyperinflation on pulmonary function and incidence of atelectasis in patients who supported by t-tube after abdominal surgery in training centers, research and treatment of Imam Reza and Ghaem hospitals in Mashhad.
In this study 40 patients who had undergone abdominal surgery randomly allocated to groups of experimental and control. Patients who were allocated in experimented group were be received pulmonary hyperinflation by using Mapleson C for two hours. Patients who were allocated in control group were be received the hospital routine treatment. For comparing the outcomes of two groups, we assessed the results of atrial blood gases, partial pressure arterial oxygen and fraction of inspired oxygen, rapid shallow breathing index (RSBI), and chest x-ray in two groups with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015103024790N1
Registration date:2016-06-01, 1395/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-01, 1395/03/12
Registrant information
Name
Mahboube Yazdani
Name of organization / entity
Nursing and Midwifery Mashhad University
Country
Iran (Islamic Republic of)
Phone
+98 51 3894 0425
Email address
yazdanim1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of manual lung hyperinflation on pulmonary function and incidence of atelectasis in patients undergoing abdominal surgery and T-tube support
Public title
Manual Lung Hyperinflation and its effect on pulmonary function and lung atelectasis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Patients are older than 18; Lack of pulmonary disorders such as Acute respiratory distress syndrome, pneumothorax, acute pulmonary edema and hemoptysis; Absence of acute infection; No history of acute Cardiovascular disorders; Patients underwent abdominal surgery; Patients should be supported by t-tube after weaning mechanical ventilation at least 2 hours; No emergency surgery or Cardiopulmonary resuscitation(CPR) before intervention; Having the ratio of partial pressure arterial oxygen and fraction of inspired oxygen more than 200; Absence of electrolyte disorders.
Exclusion Criteria: Need to get Cardiopulmonary resuscitation (CPR); Need to support by mechanical ventilation; Rise in Intracranial Pressure (ICP); Severe hemodynamic impairment; Lack of patients cooperation such as agitation; Patients who Need to reoperation or extubation
Age
From 18 years old to 85 years old
Gender
Both
Phase
2-3
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
Using a random number table for randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah Street, Qureshi Building
City
Mashhad
Postal code
Approval date
2015-06-07, 1394/03/17
Ethics committee reference number
IR.MUMS.REC.1394.247
Health conditions studied
1
Description of health condition studied
Respiratory complications after abdominal surgery
ICD-10 code
J95.2
ICD-10 code description
Acute pulmonary insufficiency following nonthoracic surgery
Primary outcomes
1
Description
Partial pressure of Oxygen (PaO2)
Timepoint
Before, 5 and 20 minutes after intervention
Method of measurement
Arterial blood gas samples
2
Description
PaCO2
Timepoint
Before, 5 and 20 minutes after intervention
Method of measurement
Arterial blood gas samples
3
Description
Estimate of arterial oxygen saturation(SaO2)
Timepoint
Before, 5 and 20 minutes after intervention
Method of measurement
Palse oxymetery
4
Description
Scoring atelectasis
Timepoint
Before and after intervention
Method of measurement
Chest X ray
5
Description
ratio of partial pressure arterial oxygen and fraction of inspired oxygen(PaO2/FiO2)
Timepoint
Before, 5 and 20 minutes after intervention
Method of measurement
Putting data in the formula
6
Description
Ratio of respiratory frequency to tidal volume( RSBI)
Timepoint
Before, 5 and 20 minutes after intervention
Method of measurement
Putting data in the formula
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After suctioning and doing arterial blood gases and chest X-ray, for two hours, hyperinflation were done. At the end of two hours, all parameters were at the beginning of intervention were recorded
Category
Other
2
Description
Control group: All actions in the intervention group without executing the manual lung hyperinflation were done.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Street address
Ahmad Abad Street
City
Mashhad
2
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Street address
West Ebn-e-Sina Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqodi
Street address
Qureshi Building, Before Golestan Intersection, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences and Health Services
Full name of responsible person
Javad Malekzadeh
Position
Bachelor' degree of nursing educatio, faculty
Other areas of specialty/work
Street address
Mashhad Nursing & Midwifery Schoo, West Ebn-e-Sina Street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Malekzadehj@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences and Health Services
Full name of responsible person
Javad Malekzadeh
Position
Bachelor' degree of nursing education, faculty
Other areas of specialty/work
Street address
Mashhad Nursing & Midwifery School, West Ebn-e-Sina Street
City
Mashhad
Postal code
Phone
+98 51 3859 5511
Fax
Email
Malekzadehj@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences and Health Services
Full name of responsible person
Mahboube Yazdani
Position
Student
Other areas of specialty/work
Street address
Nursing and Midwifery school, West Ebn-e-Sina Street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Yazdanim1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)