EFFECT OF PRE EXTUBATION MANUAL HYPERINFLATION TECHNIQUE VS REGULAR EXTUBATION AFTER STERNOTOMY
Effects of Pre-extubation Manual Hyper Inflation in Comparison to Regular Extubation Following Sternotomy.
1 other identifier
interventional
54
1 country
1
Brief Summary
Post operative pulmonary complication (PPC) is one of the cause of mortality and morbidity after sternotomy. There is no accessible confirmation which shows the impact of Pre Extubation Manual Hyperinflation method with Regular Extubation procedure. After sternotomy manual hyperinflation technique is not taken during extubation. The objective of the study was to determine the effect of Pre Extubation Manual Hyperinflation technique VS regular Extubation technique on vitals and respiratory parameters in patients after Sternotomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 18, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedNovember 12, 2020
September 1, 2020
5 months
September 18, 2020
November 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Peak expiratory flow rate
1 day
Blood pH
1 day
Blood pO2
1 day
Blood pCO2
1 day
Blood pHCO3
1 day
Pulse rate
1 day
Oxygen saturation
1 day
Forced expiratory volume
1 day
Forced vital capacity
1 day
Study Arms (2)
Regular Extubation
ACTIVE COMPARATORPre Extubation Manual Hyperinflation
EXPERIMENTALInterventions
Extubation is the removal of an endotracheal tube (ETT), which is the last step in liberating a patient from the mechanical ventilator.
Providing a larger tidal volume than baseline tidal volume to the patient and using a tidal volume which is 50% greater than that delivered by the ventilator
Eligibility Criteria
You may qualify if:
- Age 40 to 60
- Patient undergone surgery (sternotomy)
- Elective intubated (ETT orally)
- Ventilated more than 3 hours -
You may not qualify if:
- Patient with any neurological issue (mentally disturbed) who cannot understand the command
- Complicated extubation
- Pulmonary pathology where lung hyperinflation was contra-indicated (e.g. acute respiratory distress syndrome, undrained pneumothorax or exacerbation of chronic obstructive pulmonary disease and acute pulmonary edema.
- Raised intracranial pressure
- Redo or reopen. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bahria International Hospital
Rawalpindi, Punjab Province, 46000, Pakistan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2020
First Posted
November 12, 2020
Study Start
September 1, 2017
Primary Completion
February 1, 2018
Study Completion
June 1, 2018
Last Updated
November 12, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share