Endotracheal Cuff PressureNCT03902756
Comparison Between Two Endotracheal Tube Cuff Inflation Methods
A study testing Endotracheal cuff inflation in people with Endotracheal Cuff Pressure and Flow-Volume Loop Guided, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
This study is a prospective randomized controlled trial, the primary aim of this study to compare the intracuff pressure which is performed by 2 inflation methods. ( study in pediatric patients 4-12 year old) Group1 : Flow -Volume Loop-guided cuff inflation Group2 : Stethoscope-guided cuff inflation Our hypothesis is… Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Cuff Pressure, Flow-Volume Loop Guided, Stethoscope-guided
- What is being tested?
- Endotracheal cuff inflation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 5 Jun 2018to 30 May 2019
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients are undergoing an operations in Ramathibodi hospital.
- American Society of Anesthesiologists physical status class 1-2
- Endotracheal tube intubation is needed for an operation
- Consent to participate in research project.
Who cannot join
- Patient who is a predicted difficult intubation
- Patient who has lung disease, airwar abnormalities
- Patient who has pulmonary aspiration risk
- Patient who has a previous sorethroat, hoarseness, respiratory tract infection in last 2 weeks
- Refused to participate in research project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Two Endotracheal Tube Cuff Inflation Methods; Flow Volume Loop Guided vs. Just Seal by Stethoscope Guided in Pediatric Patients
This study is a prospective randomized controlled trial, the primary aim of this study to compare the intracuff pressure which is performed by 2 inflation methods. ( study in pediatric patients 4-12 year old) Group1 : Flow -Volume Loop-guided cuff inflation Group2 : Stethoscope-guided cuff inflation Our hypothesis is Flow-Volume Loop-guided cuff pressure will be lower than Stethoscope-guided cuff pressure.
This study also collect the incidence of common post-extubation respiratory adverse events coughing, hoarseness, stridor, croup as an secondary outcomes.
Read the detailed description
Historically, pediatric anesthesiologists abstained from using cuff-endotracheal tubes in children younger than 8 year of age because of the anatomical particularises of their airway and thus the increased risk of postintubation tracheal damage especially when Nitrous oxide is used for long procedures. In addition the tube size shoud be half size reduced when cuffed endotracheal tube is used, leading to higher airway resistance and increased risk of tube obstruction.
Recently, the use of Cuffed endotracheal tube has been increasing in children younger than 8 year of age who undergoing general anesthesia. Due to several reasons as follows 1) an increasingly sophisticated understanding of developing laryngeal anatomy 2) vastly improved materials in the manufacture of endotracheal tubes 3) cuffed endotracheal tubes serve several advantages over uncuffed endotracheal tubes including fewer laryngoscopies to replace ill-fitting tubes, less contamination of operating room with anesthetic gases, reliable capnography monitoring, better protection against aspiration, adequate ventilation with a low fresh gas flow which allow using low flow anesthsia, and also they are advantageous for certain operations such as laparoscopic/ airway procedures. 4) data are plentiful supporting the equal safety of using cuffed endotracheal tubes compared with uncuffed tubes in children However, using cuffed endotracheal tubes without being careful of cuff pressure may result in damage to tracheal mucosal wall especially in pediatric patients. The intra-cuff pressure should be monitored and maintained at the level below 25 cm H2O. The intra-cuff pressure more than 30 cmH2O causes obstruction to mucosal blood flow and increasing the risk of airway mucosal injury. Cuff pressure measurement by manometer is a gold standard, nevertheless manometer is not available in every operating room. Almost of anesthetists often use either manual palpation of pilot balloon or stethoscope-guided to inflate endotracheal tube cuff.
In adult studies, they found that endotracheal tube cuff pressure estimated by palpation even with experience personals is often much higher than 25-30 cmH2O. Therefore this inflation technique should be avoided in pediatric patients.
As for, stethoscope-guided endotracheal cuff inflation which pediatric anesthesiologists usually use for children. There were several studies in adult patients, they found the median cuff pressure from this inflation technique was 20 (16-28) cmH2O which is in acceptable tracheal cuff pressure.
In routine practice of general anesthesia rarely have continuous cuff pressure monitoring. When Nitrous Oxide is used for general anesthesia, the intra-cuff pressure can increase with time. Accordingly, it will be better to keep intra-cuff pressure as low as having proper sealing.
A couple studies from adult, compared endotracheal tube cuff inflation techniques between Pressure-Volume(PV) loop guided and stethoscope-guided and the results were intra-cuff pressure from PV loop guided was less than stethoscope guided. Moreover cuff-related complications ( coughing, sorethroat) were less in PV loop group also. It seems PV loop guided can provide least cuff pressure with efficient sealing.
This study would like to compare endotracheal cuff pressure that are performed by 2 techniques between Flow-Volume(FV) loop guided and stethoscope-guided in pediatric patients Intra-cuff pressure will be the primary outcome and we will also collect postoperative respiratory complications such as coughing, stridor, hoarseness as secondary outcomes.
- Being tested
- Endotracheal cuff inflation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal cuff inflationOther
Endotracheal cuff inflation is putting the air in to the endotracheal tube cuff to make the proper sealing.
| Study group | Role | What they receive |
|---|---|---|
| Flow-Volume loop guided endotracheal cuff inflation | Experimental | Endotracheal cuff will be inflated by Flow-Volume loop guided until getting proper sealing. Receives: Other: Endotracheal cuff inflation |
| Stethoscope-guided endotracheal cuff infration | Active comparator | Endotracheal cuff will be inflated by Stethoscope-guided until getting proper sealing. Receives: Other: Endotracheal cuff inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-cuff pressure
measuring intra-cuff pressure of endotracheal tube by manometer (cm H2O)
Measured: Immediately after cuff inflation
Secondary outcomes (3)
Coughing
incidence of coughing
Measured: 24 hours after extubation
Hoarseness
incidence of hoarseness
Measured: 24 hours after extubation
Stridor
incidence of stridor
Measured: 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start5 Jun 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Endotracheal Cuff PressureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Witchaya Supaopaspan, Ramathibodi Hospital
- Investigators
- Witchaya Supaopaspan, medical, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902756
- Sponsor's protocol ID
- 04-61-24ว
- Status last verified
- Mar 2020
- First submitted
- 2 Apr 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Orange FA, Andrade RG, Lemos A, Borges PS, Figueiroa JN, Kovatsis PG. Cuffed versus uncuffed endotracheal tubes for general anaesthesia in children aged eight years and under. Cochrane Database Syst Rev. 2017 Nov 17;11(11):CD011954. doi: 10.1002/14651858.CD011954.pub2.
PubMed 29149469Holzki J, Brown KA, Carroll RG, Cote CJ. The anatomy of the pediatric airway: Has our knowledge changed in 120 years? A review of historic and recent investigations of the anatomy of the pediatric larynx. Paediatr Anaesth. 2018 Jan;28(1):13-22. doi: 10.1111/pan.13281. Epub 2017 Nov 17.
PubMed 29148119Litman RS, Weissend EE, Shibata D, Westesson PL. Developmental changes of laryngeal dimensions in unparalyzed, sedated children. Anesthesiology. 2003 Jan;98(1):41-5. doi: 10.1097/00000542-200301000-00010.
PubMed 12502977Tobias JD. Pediatric airway anatomy may not be what we thought: implications for clinical practice and the use of cuffed endotracheal tubes. Paediatr Anaesth. 2015 Jan;25(1):9-19. doi: 10.1111/pan.12528. Epub 2014 Sep 20.
PubMed 25243638Dalal PG, Murray D, Feng A, Molter D, McAllister J. Upper airway dimensions in children using rigid video-bronchoscopy and a computer software: description of a measurement technique. Paediatr Anaesth. 2008 Jul;18(7):645-53. doi: 10.1111/j.1460-9592.2008.02533.x. Epub 2008 May 8.
PubMed 18482248Dalal PG, Murray D, Messner AH, Feng A, McAllister J, Molter D. Pediatric laryngeal dimensions: an age-based analysis. Anesth Analg. 2009 May;108(5):1475-9. doi: 10.1213/ane.0b013e31819d1d99.
PubMed 19372324Litman RS, Maxwell LG. Cuffed versus uncuffed endotracheal tubes in pediatric anesthesia: the debate should finally end. Anesthesiology. 2013 Mar;118(3):500-1. doi: 10.1097/ALN.0b013e318282cc8f. No abstract available.
PubMed 23314108Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric Endotracheal Intubation Study Group. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. 2009 Dec;103(6):867-73. doi: 10.1093/bja/aep290. Epub 2009 Nov 3.
PubMed 19887533Shi F, Xiao Y, Xiong W, Zhou Q, Huang X. Cuffed versus uncuffed endotracheal tubes in children: a meta-analysis. J Anesth. 2016 Feb;30(1):3-11. doi: 10.1007/s00540-015-2062-4. Epub 2015 Aug 22.
PubMed 26296534Gopalareddy V, He Z, Soundar S, Bolling L, Shah M, Penfil S, McCloskey JJ, Mehta DI. Assessment of the prevalence of microaspiration by gastric pepsin in the airway of ventilated children. Acta Paediatr. 2008 Jan;97(1):55-60. doi: 10.1111/j.1651-2227.2007.00578.x. Epub 2007 Dec 10.
PubMed 18076720Apfelbaum JL, Caplan RA, Barker SJ, Connis RT, Cowles C, Ehrenwerth J, Nickinovich DG, Pritchard D, Roberson DW, Caplan RA, Barker SJ, Connis RT, Cowles C, de Richemond AL, Ehrenwerth J, Nickinovich DG, Pritchard D, Roberson DW, Wolf GL; American Society of Anesthesiologists Task Force on Operating Room Fires. Practice advisory for the prevention and management of operating room fires: an updated report by the American Society of Anesthesiologists Task Force on Operating Room Fires. Anesthesiology. 2013 Feb;118(2):271-90. doi: 10.1097/ALN.0b013e31827773d2. No abstract available.
PubMed 23287706Black AE, Hatch DJ, Nauth-Misir N. Complications of nasotracheal intubation in neonates, infants and children: a review of 4 years' experience in a children's hospital. Br J Anaesth. 1990 Oct;65(4):461-7. doi: 10.1093/bja/65.4.461.
PubMed 2248814Dullenkopf A, Schmitz A, Gerber AC, Weiss M. Tracheal sealing characteristics of pediatric cuffed tracheal tubes. Paediatr Anaesth. 2004 Oct;14(10):825-30. doi: 10.1111/j.1460-9592.2004.01316.x.
PubMed 15385010Seegobin RD, van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. Br Med J (Clin Res Ed). 1984 Mar 31;288(6422):965-8. doi: 10.1136/bmj.288.6422.965.
PubMed 6423162Liu 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 20736432
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Endotracheal Tube Cuff Inflation Methods; Flow Volume Loop Guided vs. Just Seal by Stethoscope Guided in Pediatric Patients
- ClinicalTrials.gov ID
- NCT03902756
- Acronym / sponsor ID
- 04-61-24ว
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 4 Apr 2019 (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 study is a prospective randomized controlled trial, the primary aim of this study to compare the intracuff pressure which is performed by 2 inflation methods. ( study in pediatric patients 4-12 year old) Group1 : Flow -Volume Loop-guided cuff inflation Group2 : Stethoscope-guided cuff inflation Our hypothesis is Flow-Volume Loop-guided cuff pressure will be lower than Stethoscope-guided cuff pressure.
This study also collect the incidence of common post-extubation respiratory adverse events coughing, hoarseness, stridor, croup as an secondary outcomes.
Detailed description
Historically, pediatric anesthesiologists abstained from using cuff-endotracheal tubes in children younger than 8 year of age because of the anatomical particularises of their airway and thus the increased risk of postintubation tracheal damage especially when Nitrous oxide is used for long procedures. In addition the tube size shoud be half size reduced when cuffed endotracheal tube is used, leading to higher airway resistance and increased risk of tube obstruction.
Recently, the use of Cuffed endotracheal tube has been increasing in children younger than 8 year of age who undergoing general anesthesia. Due to several reasons as follows 1) an increasingly sophisticated understanding of developing laryngeal anatomy 2) vastly improved materials in the manufacture of endotracheal tubes 3) cuffed endotracheal tubes serve several advantages over uncuffed endotracheal tubes including fewer laryngoscopies to replace ill-fitting tubes, less contamination of operating room with anesthetic gases, reliable capnography monitoring, better protection against aspiration, adequate ventilation with a low fresh gas flow which allow using low flow anesthsia, and also they are advantageous for certain operations such as laparoscopic/ airway procedures. 4) data are plentiful supporting the equal safety of using cuffed endotracheal tubes compared with uncuffed tubes in children However, using cuffed endotracheal tubes without being careful of cuff pressure may result in damage to tracheal mucosal wall especially in pediatric patients. The intra-cuff pressure should be monitored and maintained at the level below 25 cm H2O. The intra-cuff pressure more than 30 cmH2O causes obstruction to mucosal blood flow and increasing the risk of airway mucosal injury. Cuff pressure measurement by manometer is a gold standard, nevertheless manometer is not available in every operating room. Almost of anesthetists often use either manual palpation of pilot balloon or stethoscope-guided to inflate endotracheal tube cuff.
In adult studies, they found that endotracheal tube cuff pressure estimated by palpation even with experience personals is often much higher than 25-30 cmH2O. Therefore this inflation technique should be avoided in pediatric patients.
As for, stethoscope-guided endotracheal cuff inflation which pediatric anesthesiologists usually use for children. There were several studies in adult patients, they found the median cuff pressure from this inflation technique was 20 (16-28) cmH2O which is in acceptable tracheal cuff pressure.
In routine practice of general anesthesia rarely have continuous cuff pressure monitoring. When Nitrous Oxide is used for general anesthesia, the intra-cuff pressure can increase with time. Accordingly, it will be better to keep intra-cuff pressure as low as having proper sealing.
A couple studies from adult, compared endotracheal tube cuff inflation techniques between Pressure-Volume(PV) loop guided and stethoscope-guided and the results were intra-cuff pressure from PV loop guided was less than stethoscope guided. Moreover cuff-related complications ( coughing, sorethroat) were less in PV loop group also. It seems PV loop guided can provide least cuff pressure with efficient sealing.
This study would like to compare endotracheal cuff pressure that are performed by 2 techniques between Flow-Volume(FV) loop guided and stethoscope-guided in pediatric patients Intra-cuff pressure will be the primary outcome and we will also collect postoperative respiratory complications such as coughing, stridor, hoarseness as secondary outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flow-Volume loop guided endotracheal cuff inflation | Experimental | Other: Endotracheal cuff inflationEndotracheal cuff will be inflated by Flow-Volume loop guided until getting proper sealing. |
| Stethoscope-guided endotracheal cuff infration | Active comparator | Other: Endotracheal cuff inflationEndotracheal cuff will be inflated by Stethoscope-guided until getting proper sealing. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients are undergoing an operations in Ramathibodi hospital.
- American Society of Anesthesiologists physical status class 1-2
- Endotracheal tube intubation is needed for an operation
- Consent to participate in research project.
Key exclusion criteria (5 listed)
- Patient who is a predicted difficult intubation
- Patient who has lung disease, airwar abnormalities
- Patient who has pulmonary aspiration risk
- Patient who has a previous sorethroat, hoarseness, respiratory tract infection in last 2 weeks
- Refused to participate in research project
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 cuff inflationEndotracheal cuff inflation is putting the air in to the endotracheal tube cuff to make the proper sealing. | Other | Flow-Volume loop guided endotracheal cuff inflation, Stethoscope-guided endotracheal cuff infration |
Primary outcome
Intra-cuff pressure
Time frame: Immediately after cuff inflation
measuring intra-cuff pressure of endotracheal tube by manometer (cm H2O)
3 secondary outcomes
Coughing
Time frame: 24 hours after extubation
Hoarseness
Time frame: 24 hours after extubation
Stridor
Time frame: 24 hours after extubation
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 11 Mar 2020.
- Background: PubMed 29149469De Orange FA, Andrade RG, Lemos A, Borges PS, Figueiroa JN, Kovatsis PG. Cuffed versus uncuffed endotracheal tubes for general anaesthesia in children aged eight years and under. Cochrane Database Syst Rev. 2017 Nov 17;11(11):CD011954. doi: 10.1002/14651858.CD011954.pub2.
- Background: PubMed 29148119Holzki J, Brown KA, Carroll RG, Cote CJ. The anatomy of the pediatric airway: Has our knowledge changed in 120 years? A review of historic and recent investigations of the anatomy of the pediatric larynx. Paediatr Anaesth. 2018 Jan;28(1):13-22. doi: 10.1111/pan.13281. Epub 2017 Nov 17.
- Background: PubMed 12502977Litman RS, Weissend EE, Shibata D, Westesson PL. Developmental changes of laryngeal dimensions in unparalyzed, sedated children. Anesthesiology. 2003 Jan;98(1):41-5. doi: 10.1097/00000542-200301000-00010.
- Background: PubMed 25243638Tobias JD. Pediatric airway anatomy may not be what we thought: implications for clinical practice and the use of cuffed endotracheal tubes. Paediatr Anaesth. 2015 Jan;25(1):9-19. doi: 10.1111/pan.12528. Epub 2014 Sep 20.
- Background: PubMed 18482248Dalal PG, Murray D, Feng A, Molter D, McAllister J. Upper airway dimensions in children using rigid video-bronchoscopy and a computer software: description of a measurement technique. Paediatr Anaesth. 2008 Jul;18(7):645-53. doi: 10.1111/j.1460-9592.2008.02533.x. Epub 2008 May 8.
- Background: PubMed 19372324Dalal PG, Murray D, Messner AH, Feng A, McAllister J, Molter D. Pediatric laryngeal dimensions: an age-based analysis. Anesth Analg. 2009 May;108(5):1475-9. doi: 10.1213/ane.0b013e31819d1d99.
- Background: PubMed 23314108Litman RS, Maxwell LG. Cuffed versus uncuffed endotracheal tubes in pediatric anesthesia: the debate should finally end. Anesthesiology. 2013 Mar;118(3):500-1. doi: 10.1097/ALN.0b013e318282cc8f. No abstract available.
- Background: PubMed 19887533Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric Endotracheal Intubation Study Group. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. 2009 Dec;103(6):867-73. doi: 10.1093/bja/aep290. Epub 2009 Nov 3.
- Background: PubMed 26296534Shi F, Xiao Y, Xiong W, Zhou Q, Huang X. Cuffed versus uncuffed endotracheal tubes in children: a meta-analysis. J Anesth. 2016 Feb;30(1):3-11. doi: 10.1007/s00540-015-2062-4. Epub 2015 Aug 22.
- Background: PubMed 18076720Gopalareddy V, He Z, Soundar S, Bolling L, Shah M, Penfil S, McCloskey JJ, Mehta DI. Assessment of the prevalence of microaspiration by gastric pepsin in the airway of ventilated children. Acta Paediatr. 2008 Jan;97(1):55-60. doi: 10.1111/j.1651-2227.2007.00578.x. Epub 2007 Dec 10.
- Background: PubMed 23287706Apfelbaum JL, Caplan RA, Barker SJ, Connis RT, Cowles C, Ehrenwerth J, Nickinovich DG, Pritchard D, Roberson DW, Caplan RA, Barker SJ, Connis RT, Cowles C, de Richemond AL, Ehrenwerth J, Nickinovich DG, Pritchard D, Roberson DW, Wolf GL; American Society of Anesthesiologists Task Force on Operating Room Fires. Practice advisory for the prevention and management of operating room fires: an updated report by the American Society of Anesthesiologists Task Force on Operating Room Fires. Anesthesiology. 2013 Feb;118(2):271-90. doi: 10.1097/ALN.0b013e31827773d2. No abstract available.
- Background: PubMed 2248814Black AE, Hatch DJ, Nauth-Misir N. Complications of nasotracheal intubation in neonates, infants and children: a review of 4 years' experience in a children's hospital. Br J Anaesth. 1990 Oct;65(4):461-7. doi: 10.1093/bja/65.4.461.
- 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.
Witchaya Supaopaspan, medical principal investigator
Mahidol University
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 cuff inflation in people with Endotracheal Cuff Pressure and Flow-Volume Loop Guided, run by Ramathibodi Hospital at 1 site in Thailand.
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 4 inclusion and 5 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 Mar 2020. 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 Thailand. 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?
Intra-cuff pressure (time frame: Immediately after cuff inflation). 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 NCT03902756, which also lists 23 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 Mar 2020.