HypoxemiaNCT01069185
Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning
A study testing Necessity endotracheal suctioning and Routine endotracheal suctioning in people with Hypoxemia and Arrhythmias, run by Hospital Pablo Tobón Uribe at 1 site in Colombia.
Trial summary
Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Hypoxemia, Arrhythmias, Cardiac Arrest
- What is being tested?
- Necessity endotracheal suctioning and Routine endotracheal suctioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2010to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 month to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children older than 1 month until 14 years old requiring orotracheal intubation
Who cannot join
- High frequency ventilation mode
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differences in Morbidity Frequency Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning Protocol in Hospital Pablo Tobon Uribe´s Pediatric Intensive Care Unit (PICU). A Randomized Controlled Trial
Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.
Read the detailed description
Endotracheal aspiration is a very useful procedure. It has several adverse events every time that aspiration is practiced. This trials wants to identify which protocol (necessity versus routine) could be better to practice in pediatrics intensive care unit with less risk.
- Being tested
- Necessity endotracheal suctioning, Routine endotracheal suctioning
- Keywords
- Unplanned extubation, Length of stay in PICU, Length of mechanical ventilation
- Medical subject headings
- Hypoxia, Arrhythmias, Cardiac, Heart Arrest, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Necessity endotracheal suctioningProcedure or surgery
Endotracheal suctioning depends on clinical manifestations
Routine endotracheal suctioningProcedure or surgery
Endotracheal suctioning every two hours
| Study group | Role | What they receive |
|---|---|---|
| Necessity endotracheal suctioning | Experimental | Endotracheal suctioning depends on clinical manifestations Receives: Procedure: Necessity endotracheal suctioning |
| Routine endotracheal suctioning | Other | Endotracheal suctioning every two hours Receives: Procedure: Routine endotracheal suctioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Composite End Point
All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.
Measured: Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .
Secondary outcomes (1)
Mechanical Ventilation Length as Days.
Number of days under mechanical ventilation during ICU hospitalization length
Measured: Every day while patient really is intubated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypoxemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Pablo Tobón Uribe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Lema, Hospital Pablo Tobón Uribe
- Investigators
- Gloria L Lema, MD, Principal investigator, Hospital Pablo Tobon Uribe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069185
- Sponsor's protocol ID
- 5100-66779
- Status last verified
- Sep 2017
- First submitted
- 10 Feb 2010
- Last updated
- 11 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lema-Zuluaga GL, Fernandez-Laverde M, Correa-Varela AM, Zuleta-Tobon JJ. As-needed endotracheal suctioning protocol vs a routine endotracheal suctioning in Pediatric Intensive Care Unit: A randomized controlled trial. Colomb Med (Cali). 2018 Jun 30;49(2):148-153. doi: 10.25100/cm.v49i2.2273.
PubMed 30104806
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Morbidity Frequency Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning Protocol in Hospital Pablo Tobon Uribe´s Pediatric Intensive Care Unit (PICU). A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01069185
- Acronym / sponsor ID
- 5100-66779
- Keywords
- Unplanned extubation, Length of stay in PICU, Length of mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Hospital Pablo Tobón UribeUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Posted 11 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.
Detailed description
Endotracheal aspiration is a very useful procedure. It has several adverse events every time that aspiration is practiced. This trials wants to identify which protocol (necessity versus routine) could be better to practice in pediatrics intensive care unit with less risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Necessity endotracheal suctioning | Experimental | Procedure: Necessity endotracheal suctioningEndotracheal suctioning depends on clinical manifestations |
| Routine endotracheal suctioning | Other | Procedure: Routine endotracheal suctioningEndotracheal suctioning every two hours |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children older than 1 month until 14 years old requiring orotracheal intubation
Key exclusion criteria (1 listed)
- High frequency ventilation mode
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 |
|---|---|---|
| Necessity endotracheal suctioningEndotracheal suctioning depends on clinical manifestations | Procedure or surgery | Necessity endotracheal suctioning |
| Routine endotracheal suctioningEndotracheal suctioning every two hours | Procedure or surgery | Routine endotracheal suctioning |
Primary outcome
Primary Composite End Point
Time frame: Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .
All causes of morbidity. Clinically identified as hypoxaemia, unplanned extubation, cardiac arrythmias, cardiac arrest. Measured as any change in patient´s monitor identified for ancillary nurse and/or confirmed directly by pediatrician.
1 secondary outcome
Mechanical Ventilation Length as Days.
Time frame: Every day while patient really is intubated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30104806Lema-Zuluaga GL, Fernandez-Laverde M, Correa-Varela AM, Zuleta-Tobon JJ. As-needed endotracheal suctioning protocol vs a routine endotracheal suctioning in Pediatric Intensive Care Unit: A randomized controlled trial. Colomb Med (Cali). 2018 Jun 30;49(2):148-153. doi: 10.25100/cm.v49i2.2273.
- 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.
Gloria L Lema, MD principal investigator
Hospital Pablo Tobon Uribe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Necessity endotracheal suctioning and Routine endotracheal suctioning in people with Hypoxemia and Arrhythmias, run by Hospital Pablo Tobón Uribe at 1 site in Colombia.
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 1 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 11 Sep 2017. 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 Colombia. 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?
Yes. Results are posted in the registry (first posted 11 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Composite End Point (time frame: Every component for primary outcome can be assessed during or after suctioning is applied.For routine protocol, every 2 hours for necessity protocol will depend on patient´s necessity. The assessment was done in each patient during intubation period .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01069185, which also lists 1 linked publication.
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 11 Sep 2017.