Tracheal IntubationTCP-POCNCT07264179
Tracheal Cuff Pressure and Postoperative Complications
An observational study of Tracheal Intubation and Postoperative Complications (Cardiopulmonary), run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This prospective observational study aims to identify risk factors for tracheal mucosal injuries caused by orotracheal tube use during the intraoperative period in patients undergoing elective surgeries at the Hospital de Clínicas de Porto Alegre. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Intubation, Postoperative Complications (Cardiopulmonary)
- How many people
- 362 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jan 2026to 30 Apr 2029
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.
Who may be able to join
- Age greater than 18 years.
- Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.
Who cannot join
- Age less than 18 years.
- Refusal to participate in the study.
- Surgeries performed on an urgent or emergency basis.
- Surgeries in pregnant women.
- Cardiac surgeries.
- Surgeries requiring single-lung ventilation.
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- Head and neck surgeries.
- Surgeries on the cervical segment of the dorsal spine.
- Surgeries requiring lateral or prone positioning.
- Anticipated difficult airway (unanticipated difficult airways will be included).
- Insufficient fasting time.
- Surgeries in patients admitted to intensive care units.
- Patients presenting the same symptoms included in the outcomes to be measured (pre-existing hoarseness, pain, cough, hemoptysis).
- Tracheostomized patients or those with previous tracheobronchial segment lesions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande Do Sul (RS), 90410-000
Cristiano F Andrade, MD, PhD, +55513359-6246, cfandrade@hcpa.edu.br
About this study
Official title: Tracheal Cuff Pressure and Postoperative Complications: Prospective Observational Study.
This prospective observational study aims to identify risk factors for tracheal mucosal injuries caused by orotracheal tube use during the intraoperative period in patients undergoing elective surgeries at the Hospital de Clínicas de Porto Alegre. The study will recruit patients sequentially for elective procedures requiring general anesthesia and orotracheal intubation. Primary outcomes include symptoms such as hoarseness, pharyngolaryngeal pain, cough, and hemoptysis, assessed up to 30 days post-surgery. A risk score for tracheal injuries will be derived.
Read the detailed description
Orotracheal tubes are widely used in medical practice to secure the airway and enable invasive mechanical ventilation. Modern tubes are made of medical-grade PVC with an inflatable cuff at the distal end to isolate the lower airway, prevent gas leaks from ventilation, and reduce contamination risks from upper airway secretions or gastric content. Although current cuffs are high-volume, low-pressure, overinflation complications are common, leading to variable severity lesions (isolated or confluent lesions, tracheal mucosal edema, erosions, or ulcerations with bleeding), and symptoms like dysphonia/aphonia (15-80%), cough, pain, and hemoptysis (10-15%). Overinflation can compromise tracheal mucosal perfusion, causing ischemia, necrosis, tracheoesophageal fistulas, or tracheal rupture, especially in patients requiring prolonged intubation. Even short exposures (hours) can cause significant lesions. Many physicians rely on manual palpation or experience to set cuff pressure, often inaccurately. This study will evaluate risk factors in elective surgical patients at HCPA, using multivariate regression to identify independent variables and derive a risk score.
- Keywords
- Tracheal cuff pressure, Tracheal mucosal lesions, Cough, Orotracheal tube, Postoperative hoarseness, Pharyngolaryngeal pain, Hemoptysis
- Medical subject headings
- Postoperative Complications, Cough, Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Group - Elective Surgical Patients | Single Group - Elective Surgical Patients (All patients undergoing elective surgeries with general anesthesia and orotracheal intubation; no arms as it is observational). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Tracheal Injury Symptoms (Composite Outcome).
Composite of hoarseness, pharyngolaryngeal pain, cough, and hemoptysis related to orotracheal tube use during surgery. Hoarseness, pain, and cough assessed via verbal numerical scale (0 = absent, 10 = worst possible). Hemoptysis assessed as present/absent, and volume (>100 ml/24h considered massive).
Measured: First 24 hours post-op to 30 days post-op
Secondary outcomes (1)
Independent Variables for Tracheal Complications.
Identification of independent variables (e.g., sex, age, tube duration, tube diameter, intubation attempts, unanticipated difficult airway, surgical table position, vasopressor use, comorbidities like hypertension, myocardial infarction, diabetes, peripheral arterial disease).
Measured: Intraoperative and up to 30 days post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start5 Jan 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tracheal IntubationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Andre Prato Schmidt, Hospital de Clinicas de Porto Alegre
- Investigators
- Clovis Tadeu Bevilacqua Filho, MD, MSc., Principal investigator, Serviço de Anestesia e Medicina Perioperatória, HCPA.Andre P Schmidt, MD, PhD, Study chair, Serviço de Anestesia e Medicina Perioperatória, HCPA.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264179
- Sponsor's protocol ID
- 92008125.9.0000.5327
- Acronym
- TCP-POC
- Status last verified
- Aug 2026
- First submitted
- 24 Nov 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers in its complete form. However, an anonymized database with partially included data can be shared with others if requested and for scientific purposes (including editorial requests). The data collected will be stored in REDCap and archived securely in an appropriate location, and will not be used for any purpose other than the objectives proposed by the project. All participants in the study will sign a term of commitment for the use of institutional data.
Publications
Grant T. Do current methods for endotracheal tube cuff inflation create pressures above the recommended range? A review of the evidence. J Perioper Pract. 2013 Dec;23(12):292-5. doi: 10.1177/175045891302301205.
PubMed 24404708Liu J, Zhang X, Gong W, Li S, Wang F, Fu S, Zhang M, Hang Y. Correlations between controlled endotracheal tube cuff pressure and postprocedural complications: a multicenter study. Anesth Analg. 2010 Nov;111(5):1133-7. doi: 10.1213/ANE.0b013e3181f2ecc7. Epub 2010 Aug 24.
PubMed 20736432Brodsky MB, Akst LM, Jedlanek E, Pandian V, Blackford B, Price C, Cole G, Mendez-Tellez PA, Hillel AT, Best SR, Levy MJ. Laryngeal Injury and Upper Airway Symptoms After Endotracheal Intubation During Surgery: A Systematic Review and Meta-analysis. Anesth Analg. 2021 Apr 1;132(4):1023-1032. doi: 10.1213/ANE.0000000000005276.
PubMed 33196479
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Cuff Pressure and Postoperative Complications: Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT07264179
- Acronym / sponsor ID
- TCP-POC / 92008125.9.0000.5327
- Keywords
- Tracheal cuff pressure, Tracheal mucosal lesions, Cough, Orotracheal tube, Postoperative hoarseness, Pharyngolaryngeal pain, Hemoptysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 362 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 4 Dec 2025 (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.
This prospective observational study aims to identify risk factors for tracheal mucosal injuries caused by orotracheal tube use during the intraoperative period in patients undergoing elective surgeries at the Hospital de Clínicas de Porto Alegre. The study will recruit patients sequentially for elective procedures requiring general anesthesia and orotracheal intubation. Primary outcomes include symptoms such as hoarseness, pharyngolaryngeal pain, cough, and hemoptysis, assessed up to 30 days post-surgery. A risk score for tracheal injuries will be derived.
Detailed description
Orotracheal tubes are widely used in medical practice to secure the airway and enable invasive mechanical ventilation. Modern tubes are made of medical-grade PVC with an inflatable cuff at the distal end to isolate the lower airway, prevent gas leaks from ventilation, and reduce contamination risks from upper airway secretions or gastric content. Although current cuffs are high-volume, low-pressure, overinflation complications are common, leading to variable severity lesions (isolated or confluent lesions, tracheal mucosal edema, erosions, or ulcerations with bleeding), and symptoms like dysphonia/aphonia (15-80%), cough, pain, and hemoptysis (10-15%). Overinflation can compromise tracheal mucosal perfusion, causing ischemia, necrosis, tracheoesophageal fistulas, or tracheal rupture, especially in patients requiring prolonged intubation. Even short exposures (hours) can cause significant lesions. Many physicians rely on manual palpation or experience to set cuff pressure, often inaccurately. This study will evaluate risk factors in elective surgical patients at HCPA, using multivariate regression to identify independent variables and derive a risk score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group - Elective Surgical Patients | – | –Single Group - Elective Surgical Patients (All patients undergoing elective surgeries with general anesthesia and orotracheal intubation; no arms as it is observational). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.
Key inclusion criteria (2 listed)
- Age greater than 18 years.
- Patients scheduled for elective procedures requiring general anesthesia and orotracheal intubation.
Key exclusion criteria (14 listed)
- Age less than 18 years.
- Refusal to participate in the study.
- Surgeries performed on an urgent or emergency basis.
- Surgeries in pregnant women.
- Cardiac surgeries.
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
Presence of Tracheal Injury Symptoms (Composite Outcome).
Time frame: First 24 hours post-op to 30 days post-op
Composite of hoarseness, pharyngolaryngeal pain, cough, and hemoptysis related to orotracheal tube use during surgery. Hoarseness, pain, and cough assessed via verbal numerical scale (0 = absent, 10 = worst possible). Hemoptysis assessed as present/absent, and volume (>100 ml/24h considered massive).
1 secondary outcome
Independent Variables for Tracheal Complications.
Time frame: Intraoperative and up to 30 days post-op.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Results publication: PubMed 24404708Grant T. Do current methods for endotracheal tube cuff inflation create pressures above the recommended range? A review of the evidence. J Perioper Pract. 2013 Dec;23(12):292-5. doi: 10.1177/175045891302301205.
- Results publication: PubMed 20736432Liu J, Zhang X, Gong W, Li S, Wang F, Fu S, Zhang M, Hang Y. Correlations between controlled endotracheal tube cuff pressure and postprocedural complications: a multicenter study. Anesth Analg. 2010 Nov;111(5):1133-7. doi: 10.1213/ANE.0b013e3181f2ecc7. Epub 2010 Aug 24.
- Results publication: PubMed 33196479Brodsky MB, Akst LM, Jedlanek E, Pandian V, Blackford B, Price C, Cole G, Mendez-Tellez PA, Hillel AT, Best SR, Levy MJ. Laryngeal Injury and Upper Airway Symptoms After Endotracheal Intubation During Surgery: A Systematic Review and Meta-analysis. Anesth Analg. 2021 Apr 1;132(4):1023-1032. doi: 10.1213/ANE.0000000000005276.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers in its complete form. However, an anonymized database with partially included data can be shared with others if requested and for scientific purposes (including editorial requests). The data collected will be stored in REDCap and archived securely in an appropriate location, and will not be used for any purpose other than the objectives proposed by the project. All participants in the study will sign a term of commitment for the use of institutional data.
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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.
Clovis Tadeu Bevilacqua Filho, MD, MSc. principal investigator
Serviço de Anestesia e Medicina Perioperatória, HCPA.
Andre P Schmidt, MD, PhD study chair
Serviço de Anestesia e Medicina Perioperatória, HCPA.
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 Tracheal Intubation and Postoperative Complications (Cardiopulmonary), run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 2 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clovis Tadeu Bevilacqua Filho, MD, MSc. (+555198133-5024, clovisfilho@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Tracheal Injury Symptoms (Composite Outcome). (time frame: First 24 hours post-op to 30 days post-op). 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 NCT07264179, which also lists 3 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 11 Aug 2026.