NCT05489809

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

July 26, 2022

Last Update Submit

August 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Pulse

    3 months

  • Oxygen saturation

    3 months

  • Blood pressure

    3 months

  • Supplemental oxygen

    3 months

  • Airway suctioning

    3 months

Study Arms (2)

Endotracheal extubation with suctioning

EXPERIMENTAL

Suctioning is applied to the endotracheal tube while removing it.

Procedure: Endotracheal extubation with suctioning

Endotracheal extubation with positive pressure

EXPERIMENTAL

Positive pressure is applied to the endotracheal tube while removing it.

Procedure: Endotracheal extubation with positive pressure

Interventions

General anestheisa is maintained with an endotracheal tube. At the end of anesthesia, the endotracheal tube is removed by applying suctioning.

Endotracheal extubation with suctioning

General anesthesia is maintained with an endotracheal tube. At the end of anesthesia, the endotracheal tube is removed by applying positive pressure.

Endotracheal extubation with positive pressure

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PNS Shifa Hospital

Karachi, Sindh, 46000, Pakistan

Location

MeSH Terms

Interventions

Airway ExtubationSuction

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsInvestigative TechniquesDrainageSurgical Procedures, Operative

Study Officials

  • Kenan Khan

    Pakistan Navy Station Shifa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graded Anaesthetist, Principal Investigator

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 5, 2022

Study Start

April 1, 2022

Primary Completion

June 30, 2022

Study Completion

July 15, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations