Endotracheal ExtubationNCT05489809
Endotracheal Extubation With Suctioning Versus Positive Pressure in Children After General Anaesthesia.
A study testing Endotracheal extubation with suctioning and Endotracheal extubation with positive pressure in people with Endotracheal Extubation, run by Pakistan Navy Station Shifa Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Endotracheal Extubation
- What is being tested?
- Endotracheal extubation with suctioning and Endotracheal extubation with positive pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I/II patients
- either sex
- consent given
Who cannot join
- not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endotracheal Extubation
- Being tested
- Endotracheal extubation with suctioning, Endotracheal extubation with positive pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal extubation with suctioningProcedure or surgery
General anestheisa is maintained with an endotracheal tube. At the end of anesthesia, the endotracheal tube is removed by applying suctioning.
Endotracheal extubation with positive pressureProcedure or surgery
General anesthesia is maintained with an endotracheal tube. At the end of anesthesia, the endotracheal tube is removed by applying positive pressure.
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal extubation with suctioning | Experimental | Suctioning is applied to the endotracheal tube while removing it. Receives: Procedure: Endotracheal extubation with suctioning |
| Endotracheal extubation with positive pressure | Experimental | Positive pressure is applied to the endotracheal tube while removing it. Receives: Procedure: Endotracheal extubation with positive pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Pulse
Heart rate in beats per minute
Measured: 3 months
Oxygen saturation
Oxygen saturation in percentage
Measured: 3 months
Blood pressure
Blood pressure in millimetre of mercury
Measured: 3 months
Supplemental oxygen
Supplemental oxygen in liters per min
Measured: 3 months
Airway suctioning
Number of times suctioning required to clear airway secretions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Apr 2022
- Primary completion30 Jun 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal ExtubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Navy Station Shifa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenan Anwar Khan, Pakistan Navy Station Shifa Hospital
- Investigators
- Kenan Khan, Principal investigator, Pakistan Navy Station Shifa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489809
- Sponsor's protocol ID
- ERC/2022/ANS/2
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endotracheal Extubation With Suctioning Versus Positive Pressure in Children After General Anaesthesia. A Randomised Control Trial.
- ClinicalTrials.gov ID
- NCT05489809
- Acronym / sponsor ID
- ERC/2022/ANS/2
- Conditions
- Endotracheal Extubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pakistan Navy Station Shifa HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal extubation with suctioning | Experimental | Procedure: Endotracheal extubation with suctioningSuctioning is applied to the endotracheal tube while removing it. |
| Endotracheal extubation with positive pressure | Experimental | Procedure: Endotracheal extubation with positive pressurePositive pressure is applied to the endotracheal tube while removing it. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I/II patients
- either sex
- consent given
Key exclusion criteria (1 listed)
- not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal extubation with suctioningGeneral anestheisa is maintained with an endotracheal tube. At the end of anesthesia, the endotracheal tube is removed by applying suctioning. | Procedure or surgery | Endotracheal extubation with suctioning |
| Endotracheal extubation with positive pressureGeneral anesthesia is maintained with an endotracheal tube. At the end of anesthesia, the endotracheal tube is removed by applying positive pressure. | Procedure or surgery | Endotracheal extubation with positive pressure |
Primary outcome
Endotracheal extubation
Time frame: 3 months
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.
5 secondary outcomes
Pulse
Time frame: 3 months
Oxygen saturation
Time frame: 3 months
Blood pressure
Time frame: 3 months
Supplemental oxygen
Time frame: 3 months
Airway suctioning
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenan Khan principal investigator
Pakistan Navy Station Shifa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal extubation with suctioning and Endotracheal extubation with positive pressure in people with Endotracheal Extubation, run by Pakistan Navy Station Shifa Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal extubation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.