Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001312730
Ethics application status
Approved
Date submitted
22/08/2022
Date registered
11/10/2022
Date last updated
11/10/2022
Date data sharing statement initially provided
11/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Yoga breathing and respiratory complications in surgical patients
Scientific title
Impact of yoga breathing exercises on postoperative pulmonary complications after major abdominal surgery: randomized controlled study
Secondary ID [1] 307735 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pulmonary complications 327311 0
surgical stress response 327348 0
Condition category
Condition code
Respiratory 324439 324439 0 0
Other respiratory disorders / diseases
Anaesthesiology 324442 324442 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients planned for elective abdominal surgery (laparoscopy or laparotomy) were required to attend preoperative evaluation by anesthesiologist in outpatient clinic approximately a week before surgery. Patients who were eligible for the study were given oral and written instructions about breathing exercise performance. The participants in subject group should start the exercises in preoperative period (during 5 to 7 days) and continue it during the 5 postoperative days. Expected duration of each breathing session is 7 minutes. The subject group performed yoga breathing exercises-pranayama, consisting of seven consecutive cycles of alternate nasal breathing. Each cycle begins with deep inhalation through left nostril, preceded by deep exhalation. After holding the breath for few seconds, exhalation through right nostril takes place followed by inhalation through right nostril and exhalation through left nostril. Upon exhalation through left nostril, the breathing cycle is completed and the next one takes place immediately by inspiration through left nostril. The participants should performed seven breathing cycles once a day for 5 consecutive preoperative and postoperative days. Deep and slow breathing is recommended. Participants are instructed to stop the breathing exercises if any kind of discomfort occurs (dizziness, nausea, unpleasant feeling of dyspnea etc). It will be noted in medical record. Airflow through nostrils is regulated by right hand. During inhalation through left nostril, the right one is closed by right thumb. The ring finger of right hand is used to close the left nostril, while exhalation is performed through the right one. Peak expiratory flow (PEF) is assessed along with partial pressure of oxygen (paO2), paCO2 (partial pressure of carbon dioxide) and SaO2(saturation of arterial blood by oxygen) measured via arterial blood gas sample in preoperatively. Neutrophil to lymphocyte ratio (NLR), C-reactive protein (CRP) and albumin are part of routine preoperative laboratory evaluation before major abdominal surgery and data is available in medical record. ARISCAT score was calculated for each patient which was based on seven independent risk factors for PPC: preoperative arterial oxygen saturation, acute respiratory infection during the previous month, age of the patient, preoperative hemoglobin levels, site of surgery, duration of surgery, and emergency surgery. Adherence to above mentioned protocol will be checked by written questionnaire that will be given to patients at the end of the fifth postoperative day.
Intervention code [1] 324208 0
Prevention
Comparator / control treatment
In control group standard preoperative evaluation was performed by anesthesiologist. In addition to standard assessment, PEF was measured and ARISCAT score was calculated. No breathing exercises were performed in perioperative period. Besides standard laboratory examination (NLR, CRP, albumin), blood oxygenation parameters (paO2, SaO2) and paCO2 were assessed from arterial blood gas sample a day before surgery and on postoperative days 1, 3 and 5. Blood sample was withdrawn to determine NLR, CRP and albumin on postoperative days 1 and 5.
Control group
Active

Outcomes
Primary outcome [1] 332296 0
The primary purpose of this study was to investigate the influence of perioperative yoga breathing exercises on the incidence of postoperative pulmonary complications after major abdominal surgery within 5 postoperative days
Timepoint [1] 332296 0
Measurement of peak expiratory flow (PEF) along with clinical assessment of patients respiratory status in postoperative period was carried out at baseline and one hour after extubation in recovery room (to avoid interference of residual anesthetic activity on respiratory system), and on postoperative days 3 and 5 in surgical ward. Respiratory status of patients was evaluate on daily basis, but for the purpose of this study, it was recorded on postoperative days 1, 3, 5. Data has been available from medical history and medical electronic records.
Primary outcome [2] 332624 0
To determine whether yoga breathing exercises affect the oxygenation status of arterial blood after major abdominal surgery within 5 postoperative days.
Timepoint [2] 332624 0
Parameters of arterial blood oxygenation- pa02 ( partial pressure of oxygen), SaO2 (saturation of arterial blood by oxygen) and ventilation- paCO2 (partial pressure of arterial carbon dioxide) measured via arterial blood gas sample were recorded at baseline and on postoperative days 1, 3 and 5, Assessment in postoperative period was carried out one hour after extubation in recovery room (to avoid interference of residual anesthetic activity on respiratory system) and on postoperative days 3 and 5 in surgical ward. Data has been available from medical history and medical electronic records.
Secondary outcome [1] 412869 0
The secondary goal was to establish whether yoga breathing exercises impact the parameters of surgical stress response after major abdominal surgery.
Timepoint [1] 412869 0
NLR, CRP and albumin were determined at baseline and on postoperative days 1 and 5 from the patients' blood samples. Data has been available from medical history and medical electronic records.

Eligibility
Key inclusion criteria
American Society of Anesthesiologists (ASA) physical status I-III. Patients who undergone elective abdominal surgery (open or laparoscopic) under general anesthesia with predicted duration of general anesthesia of more than 2 hours, ARISCAT score equal or greater than 26.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy. Intraoperative and postoperative respiratory and haemodynamic instability which hinder breathing exercises. Patients who are already intubated and mechanically ventilated before surgery. Transplantation surgery. Locomotor and cognitive limitations which preclude exercise performance. Participants who refused to be involved in the study. Patient undergoing outpatients procedures (hospital stay of less than 24 hours), emergency procedures,

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/03/2022
Date of last participant enrolment
Anticipated
23/12/2022
Actual
Date of last data collection
Anticipated
28/12/2022
Actual
Sample size
Target
60
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 24968 0
Croatia
State/province [1] 24968 0

Funding & Sponsors
Funding source category [1] 312004 0
Hospital
Name [1] 312004 0
University Hospital Centre Sestre milosrdnice
Country [1] 312004 0
Croatia
Primary sponsor type
Individual
Name
Iva Pažur
Address
University Hospital Centre Sestre milosrdnice, Vinogradska cesta 29, 10000 Zagreb, Croatia
Country
Croatia
Secondary sponsor category [1] 313609 0
None
Name [1] 313609 0
none
Address [1] 313609 0
none
Country [1] 313609 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311426 0
Ethical Committee of University Hospital Clinical Centre Sestre Milosrdnice
Ethics committee address [1] 311426 0
Ethics committee country [1] 311426 0
Croatia
Date submitted for ethics approval [1] 311426 0
Approval date [1] 311426 0
06/06/2019
Ethics approval number [1] 311426 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121054 0
Dr Iva Pažur
Address 121054 0
University Hospital Centre Sestre milosrdnice, Vinogradska cesta 29, 10000 Zagreb
Country 121054 0
Croatia
Phone 121054 0
+385 91 6050 924
Fax 121054 0
Email 121054 0
[email protected]
Contact person for public queries
Name 121055 0
Iva Pažur
Address 121055 0
University Hospital Centre Sestre milosrdnice, Vinogradska cesta 29, 10000 Zagreb
Country 121055 0
Croatia
Phone 121055 0
+385 91 6050 924
Fax 121055 0
Email 121055 0
[email protected]
Contact person for scientific queries
Name 121056 0
Iva Pažur
Address 121056 0
University Hospital Centre Sestre milosrdnice, Vinogradska cesta 29, 10000 Zagreb
Country 121056 0
Croatia
Phone 121056 0
+385 91 6050 924
Fax 121056 0
Email 121056 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.