Spine DiseaseSIPBIENCT05889611
Iterative Endotracheal Tube Cuff Pressure Monitoring
An observational study of Spine Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Studies in the medical literature underline the importance of monitoring the pressure of the balloon and the relationship with the incidence cited on the pain and discomfort related to the gesture of the upper airways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Disease
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2023to 22 Mar 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adult patient who has a scheduled spine intervention in the prone position from January 1, 2023 to April 30, 2023.
Who may be able to join
- Elderly patient ≥ 18 years old
- Patient who has a scheduled spine intervention in the prone position from January 1, 2023 to April 30, 2023
- Intubated patient with endotracheal tube under mechanical ventilation
- Sedation and curarization
- ASA 1, 2 and 3
- Duration of surgery > 1 hour
- Subject not objecting to the reuse of their data for the purposes of this research.
Who cannot join
- Subject who expressed their opposition to participating in the study
- ASA 4, difficult intubation and emergency
- Lung pathologies (asthma, COPD, tracheomalacia)
- Severe heart failure
- Septic, cardiogenic or volume shock
- Morbid obesity (BMI >40)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France
Strasbourg, 67091
Nicolas PARTOUCHE, MD, 33 3 68 76 51 09, nicolas.partouche@chru-strasbourg.fr
Nicolas PARTOUCHE, MD
About this study
Studies in the medical literature underline the importance of monitoring the pressure of the balloon and the relationship with the incidence cited on the pain and discomfort related to the gesture of the upper airways. There are no formal recommendations in the literature, the French Society of Anesthesia and Resuscitation (SFAR) recommends monitoring the pressure intraoperatively except after intubation. It would be interesting to see and thus make an inventory of the practices, to reiterate the importance of monitoring throughout the gesture and at the change of position to avoid either micro-inhalation linked to under pressure of the balloon or overpressure which causes a potential risk of tracheal injury.
- Conditions
- Spine Disease
- Keywords
- Spine Disease, Spine surgery, Intubation Cuff Pressure, Endotracheal Intubation, Upper airways
- Medical subject headings
- Spinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Balloon pressure
Monitoring of balloon pressure following prone position during spine surgery
Measured: Throughout the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start22 Mar 2023
- Primary completion22 Mar 2024 (estimated)
- Study completion22 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas PARTOUCHE, MD, Study director, University Hospitals of Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889611
- Sponsor's protocol ID
- 8904
- Acronym
- SIPBIE
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iterative Endotracheal Tube Cuff Pressure Monitoring
- ClinicalTrials.gov ID
- NCT05889611
- Acronym / sponsor ID
- SIPBIE / 8904
- Conditions
- Spine Disease
- Keywords
- Spine Disease, Spine surgery, Intubation Cuff Pressure, Endotracheal Intubation, Upper airways
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 22 Mar 2024 (estimated)
- Study completion
- 22 Mar 2024 (estimated)
- First posted
- 5 Jun 2023 (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.
Studies in the medical literature underline the importance of monitoring the pressure of the balloon and the relationship with the incidence cited on the pain and discomfort related to the gesture of the upper airways. There are no formal recommendations in the literature, the French Society of Anesthesia and Resuscitation (SFAR) recommends monitoring the pressure intraoperatively except after intubation. It would be interesting to see and thus make an inventory of the practices, to reiterate the importance of monitoring throughout the gesture and at the change of position to avoid either micro-inhalation linked to under pressure of the balloon or overpressure which causes a potential risk of tracheal injury.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patient who has a scheduled spine intervention in the prone position from January 1, 2023 to April 30, 2023.
Key inclusion criteria (7 listed)
- Elderly patient ≥ 18 years old
- Patient who has a scheduled spine intervention in the prone position from January 1, 2023 to April 30, 2023
- Intubated patient with endotracheal tube under mechanical ventilation
- Sedation and curarization
- ASA 1, 2 and 3
Key exclusion criteria (6 listed)
- Subject who expressed their opposition to participating in the study
- ASA 4, difficult intubation and emergency
- Lung pathologies (asthma, COPD, tracheomalacia)
- Severe heart failure
- Septic, cardiogenic or volume shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Balloon pressure
Time frame: Throughout the surgical procedure
Monitoring of balloon pressure following prone position during spine surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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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.
Nicolas PARTOUCHE, MD study director
University Hospitals of Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Disease, run by University Hospital, Strasbourg, France at 1 site in France.
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 7 inclusion and 6 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 15 Jun 2023. 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 France. 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 Nicolas PARTOUCHE, MD (33 3 68 76 51 09, nicolas.partouche@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balloon pressure (time frame: Throughout the surgical procedure). 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 15 Jun 2023.