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.

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.

Study Overview

• Status: Completed
• Conditions: Sternotomy
• Intervention / Treatment: Procedure: Extubation; Procedure: Manual Hyperinflation

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Bahria International Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 40 to 60
2. Patient undergone surgery (sternotomy)
3. Elective intubated (ETT orally)
4. Ventilated more than 3 hours -

Exclusion Criteria:

1. Patient with any neurological issue (mentally disturbed) who cannot understand the command
2. Complicated extubation
3. 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.
4. Raised intracranial pressure
5. Redo or reopen. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular Extubation	Procedure: Extubation; Extubation is the removal of an endotracheal tube (ETT), which is the last step in liberating a patient from the mechanical ventilator.
Experimental: Pre Extubation Manual Hyperinflation	Procedure: Extubation; Extubation is the removal of an endotracheal tube (ETT), which is the last step in liberating a patient from the mechanical ventilator.; Procedure: Manual Hyperinflation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Extubation; Sternotomy; Manual Hyperinflation
• Other Study ID Numbers: FUI/CTR/2020/7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No