Endotracheal Extubation With Suctioning Versus Positive Pressure in Children After General Anaesthesia.

Endotracheal Extubation With Suctioning Versus Positive Pressure in Children After General Anaesthesia. A Randomised Control Trial.

Comparing extubation of endotracheal tube in children after general anaesthesia by applying suctioning to the endotracheal tube versus applying positive pressure to the endotracheal tube.

Study Overview

• Status: Completed
• Conditions: Endotracheal Extubation
• Intervention / Treatment: Procedure: Endotracheal extubation with suctioning; Procedure: Endotracheal extubation with positive pressure

Detailed Description

Extubation after general anaesthesia involves removal of the endotracheal tube. This is done by either applying suctioning or applying positive pressure to the endotracheal tube. My study aims at identifying which technique is superior to the other.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan, 46000
      • PNS Shifa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I/II patients
• either sex
• consent given

Exclusion Criteria:

• not meeting the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endotracheal extubation with suctioning; Suctioning is applied to the endotracheal tube while removing it.	Procedure: Endotracheal extubation with suctioning; General anestheisa is maintained with an endotracheal tube. At the end of anesthesia, the endotracheal tube is removed by applying suctioning.
Experimental: Endotracheal extubation with positive pressure; Positive pressure is applied to the endotracheal tube while removing it.	Procedure: Endotracheal extubation with positive pressure; General anesthesia is maintained with an endotracheal tube. At the end of anesthesia, the endotracheal tube is removed by applying positive pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endotracheal extubation	The intervention will try to identify which technique is better to extubate the patient after general anesthesia. In literature/anesthesia practice there is no scale, parameter or questionnaire to indicate extubation. However the aim is universally accepted that is to extubate the patient when he/she is hemodynamically stable and able to maintain a patent airway and oxygen saturation while spontaneously breathing and awake. In my trial, half the number of participants will be extubated by applying suctioning to the endotracheal tube and the remaining will be extubated by applying positive pressure to the endotracheal tube at the end of general anesthesia. Patients heart rate, blood pressure, oxygen saturation, the need for clearing secretions from the airway, and the need for supplemental oxygen at the time of extubation and 3 minutes after extubation will be compared to identify which technique is better in terms of patients airway management.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse	Heart rate in beats per minute	3 months
Oxygen saturation	Oxygen saturation in percentage	3 months
Blood pressure	Blood pressure in millimetre of mercury	3 months
Supplemental oxygen	Supplemental oxygen in liters per min	3 months
Airway suctioning	Number of times suctioning required to clear airway secretions	3 months

Collaborators and Investigators

• Sponsor: Pakistan Navy Station Shifa Hospital
• Investigators: Principal Investigator: Kenan Khan, Pakistan Navy Station Shifa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ERC/2022/ANS/2

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