ComplicationNCT03174509
Is Positive Pressure Extubation a Safe Procedure?
A study testing Positive pressure extubation and Traditional during extubation in people with Complication, run by Hospital Donación Francisco Santojanni at 1 site in Argentina.
Trial summary
Laboratory studies suggest extubation with positive pressure because it reduces the volume of secretions filtered into the distal airway. The aim of this non inferiority study is to evaluate the safety of the extubation technique under positive pressure with respect to the traditional technique (with suction and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication
- What is being tested?
- Positive pressure extubation and Traditional during extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jan 2017to 31 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive Mechanical Ventilation with endotracheal tube.
- 18 years and older.
- Successful 30 minutes spontaneous breathing trial (SBT).
- Extubation Criteria.
- Informed consent.
Who cannot join
- Previous airway surgery or injury.
- Non-Invasive Ventilation as weaning method.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Hospital Santojanni
Buenos Aires, 1408
Mauro F Andreu, PT, 54 11 1568788298, maufede@hotmail.com
Marco G Bezzi, PT, 54 11 1550620219, bezzi.marco@gmail.com
About this study
Official title: Is Positive Pressure Extubation Safe Procedure? A Randomized Non-inferiority Trial.
Laboratory studies suggest extubation with positive pressure because it reduces the volume of secretions filtered into the distal airway. The aim of this non inferiority study is to evaluate the safety of the extubation technique under positive pressure with respect to the traditional technique (with suction and without positive pressure in the airways).
Read the detailed description
The extubation procedure consists of the removal of the endotracheal tube when it is no longer required. The literature reports two methods of extubation: the named traditional method (with suction and without positive pressure in the airways) and the positive pressure method. Laboratory studies suggest extubation at positive pressure because it reduces the volume of secretions filtered into the distal airway. Prior to apply it into clinical practice the investigators of this study consider is a priority to guarantee the safety of the positive pressure extubation method in terms of presence of complications.
The aim of this non-inferiority study is to compare the incidence of complications between both extubation techniques in adult patients with invasive mechanical ventilation.
The hypothesis of this study is that applying positive pressure during cuff deflation and extubation is not inferior to the traditional method in the incidence of complications.
- Conditions
- Complication
- Being tested
- Positive pressure extubation, Traditional during extubation
- Keywords
- airway extubation, positive-pressure respiration, suction, ventilator weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive pressure extubationProcedure or surgery
Positive pressure ventilation without endotracheal aspiration/suction during extubation procedure.
Traditional during extubationProcedure or surgery
Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure.
| Study group | Role | What they receive |
|---|---|---|
| Positive Pressure Extubation | Active comparator | Positive pressure extubation is used for patients in this group. Receives: Procedure: Positive pressure extubation |
| Traditional Extubation | Active comparator | Traditional extubation is used for patients in this group. Receives: Procedure: Traditional during extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/A presence/absence of complications after extubation
Clinical Evidence of at least one of the next complications: persistent cough, airway obstruction, post-obstructive pulmonary edema, bronchospasm, desaturation, vomiting, tachycardia, arterial hypertension.
Measured: 60 minutes
Secondary outcomes (2)
Pneumonia
Presence of fever, leukocytosis, purulent secretions and a new pulmonary infiltrate on chest radiography
Measured: 72 hours
Reintubation
Intubation requirement after extubation
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start1 Jan 2017
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ComplicationStudies 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
- Model description
- Non-inferiority trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Donación Francisco Santojanni
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Andreu, Hospital Donación Francisco Santojanni
- Investigators
- Mauro F Andreu, PT, Principal investigator, Hospital D. F. Santojanni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174509
- Sponsor's protocol ID
- HGADFS14012016-01
- Status last verified
- Jun 2017
- First submitted
- 30 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Andreu MF, Salvati IG, Donnianni MC, Ibanez B, Cotignola M, Bezzi M. Effect of applying positive pressure with or without endotracheal suctioning during extubation: a laboratory study. Respir Care. 2014 Dec;59(12):1905-11. doi: 10.4187/respcare.03121. Epub 2014 Nov 25.
PubMed 25425709Andreu MF, Dotta ME, Bezzi MG, Borello S, Cardoso GP, Dib PC, Garcia Schustereder SL, Galloli AM, Castro DR, Di Giorgio VL, Villalba FJ, Bertozzi MN, Carballo JM, Martin MC, Brovia CC, Pita MC, Pedace MP, De Benedetto MF, Delli Carpini J, Aguirre P, Montero G. Safety of Positive Pressure Extubation Technique. Respir Care. 2019 Aug;64(8):899-907. doi: 10.4187/respcare.06541. Epub 2019 Mar 26.
PubMed 30914493
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Positive Pressure Extubation Safe Procedure? A Randomized Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT03174509
- Acronym / sponsor ID
- HGADFS14012016-01
- Conditions
- Complication
- Keywords
- airway extubation, positive-pressure respiration, suction, ventilator weaning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Hospital Donación Francisco SantojanniUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 2 Jun 2017 (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.
Laboratory studies suggest extubation with positive pressure because it reduces the volume of secretions filtered into the distal airway. The aim of this non inferiority study is to evaluate the safety of the extubation technique under positive pressure with respect to the traditional technique (with suction and without positive pressure in the airways).
Detailed description
The extubation procedure consists of the removal of the endotracheal tube when it is no longer required. The literature reports two methods of extubation: the named traditional method (with suction and without positive pressure in the airways) and the positive pressure method. Laboratory studies suggest extubation at positive pressure because it reduces the volume of secretions filtered into the distal airway. Prior to apply it into clinical practice the investigators of this study consider is a priority to guarantee the safety of the positive pressure extubation method in terms of presence of complications.
The aim of this non-inferiority study is to compare the incidence of complications between both extubation techniques in adult patients with invasive mechanical ventilation.
The hypothesis of this study is that applying positive pressure during cuff deflation and extubation is not inferior to the traditional method in the incidence of complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Positive Pressure Extubation | Active comparator | Procedure: Positive pressure extubationPositive pressure extubation is used for patients in this group. |
| Traditional Extubation | Active comparator | Procedure: Traditional during extubationTraditional extubation is used for patients in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Invasive Mechanical Ventilation with endotracheal tube.
- 18 years and older.
- Successful 30 minutes spontaneous breathing trial (SBT).
- Extubation Criteria.
- Informed consent.
Key exclusion criteria (2 listed)
- Previous airway surgery or injury.
- Non-Invasive Ventilation as weaning method.
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 |
|---|---|---|
| Positive pressure extubationPositive pressure ventilation without endotracheal aspiration/suction during extubation procedure. | Procedure or surgery | Positive Pressure Extubation |
| Traditional during extubationSpontaneous ventilation with endotracheal aspiration/suction during extubation procedure. | Procedure or surgery | Traditional Extubation |
Primary outcome
Presence/A presence/absence of complications after extubation
Time frame: 60 minutes
Clinical Evidence of at least one of the next complications: persistent cough, airway obstruction, post-obstructive pulmonary edema, bronchospasm, desaturation, vomiting, tachycardia, arterial hypertension.
2 secondary outcomes
Pneumonia
Time frame: 72 hours
Reintubation
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Background: PubMed 25425709Andreu MF, Salvati IG, Donnianni MC, Ibanez B, Cotignola M, Bezzi M. Effect of applying positive pressure with or without endotracheal suctioning during extubation: a laboratory study. Respir Care. 2014 Dec;59(12):1905-11. doi: 10.4187/respcare.03121. Epub 2014 Nov 25.
- Derived from this study: PubMed 30914493Andreu MF, Dotta ME, Bezzi MG, Borello S, Cardoso GP, Dib PC, Garcia Schustereder SL, Galloli AM, Castro DR, Di Giorgio VL, Villalba FJ, Bertozzi MN, Carballo JM, Martin MC, Brovia CC, Pita MC, Pedace MP, De Benedetto MF, Delli Carpini J, Aguirre P, Montero G. Safety of Positive Pressure Extubation Technique. Respir Care. 2019 Aug;64(8):899-907. doi: 10.4187/respcare.06541. Epub 2019 Mar 26.
- Individual participant dataSharing planned: Undecided
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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.
Mauro F Andreu, PT principal investigator
Hospital D. F. Santojanni
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive pressure extubation and Traditional during extubation in people with Complication, run by Hospital Donación Francisco Santojanni at 1 site in Argentina.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Jun 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 Argentina. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauro F Andreu, PT (54 11 156878298, maufede@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/A presence/absence of complications after extubation (time frame: 60 minutes). 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 NCT03174509, which also lists 2 linked publications.
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 Jun 2017.