Tracheal DamageLOR-ETCPNCT02294422
Balloon Palpation vs Loss of Resistance Syringe for Safe Endotracheal Tube Cuff Pressure; a Randomized Clinical Trial
A study testing PBP, LOR and Aneroid manometer in people with Tracheal Damage, run by Makerere University at 1 site in Uganda.
Trial summary
This study is aimed at establishing whether use of loss of resistance syringe (LOR) that is traditionally used for identifying epidural space, is a better method for providing safe cuff pressures in adults intubated with cuffed endotracheal tubes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Damage
- What is being tested?
- PBP, LOR and Aneroid manometer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteUganda
- Study dates
- Apr 2014to Feb 2015
- 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
- American society of anesthesiologists (ASA) physical status classes I-IV
Who cannot join
- Known or anticipated laryngo-tracheal abnormalities.
- Patients with cough, sore throat, dysphagia and dysphonia.
- Patients in whom intubation is attempted more than twice
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Makerere University college of health sciences, Mulago National Referal Hospital Complex
Kampala, 256
About this study
Official title: Achieving Recommended Endotracheal Tube Cuff Pressure; A Randomized Control Trial Comparing Loss of Resistance Syringe to Pilot Balloon Palpation.
This study is aimed at establishing whether use of loss of resistance syringe (LOR) that is traditionally used for identifying epidural space, is a better method for providing safe cuff pressures in adults intubated with cuffed endotracheal tubes. The conventional method is the use of pilot ballon palpation (PBP) to approximate cuff pressures but this is associated with airway damage.
The study hypothesis states that both the loss of resistance syringe method and the pilot balloon palpation methods achieve the recommended endotracheal tube intracuff pressures.
- Conditions
- Tracheal Damage
- Being tested
- PBP, LOR, Aneroid manometer
- Keywords
- Loss of resistance, Pilot balloon, Cuff pressure, Endotracheal tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBPDevice
Also called Pilot balloon palpation technique
the pilot balloon is continuously palpated o felt for adequate pressure as its being inflated.
LORDevice
Also called LOR syinge
Aneroid manometerDevice
Also called VBM, Germany
The pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge.
| Study group | Role | What they receive |
|---|---|---|
| 2. LOR and aneroid manometer group | Experimental | after inflating the endotracheal tube (ETT) cuff using a loss of resistance syringe (BD Epillor LOR), the LOR syringe is left attached to the pilot balloon and and any excess pressure will be passively released until the plunger stops drawing back. Receives: Device: LOR; Device: Aneroid manometer |
| 1. PBP and aneroid manometer group | Placebo comparator | The anaesthesia care provider shall inflate the ETT cuff via the pilot balloon with small volumes of air as he/she 'feels ' for the pressures in the pilot balloon to a pressure he/she thinks is just enough. An aneroid manometer (VBM, Germany. Accurate in the range 0-120 cmH2O +-2 cmH2O) shall then be attached by the investigator and measurement of the pressure taken. Receives: Device: PBP; Device: Aneroid manometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O
This outcome will be measured within the first 5 minutes after intubation of the patient. The recommended range of intracuff pressure for this study is 20-30cmH2O
Measured: 5minutes
Secondary outcomes (1)
Incidence of early postoperative airway symptoms
Patents will be reviewed 12 hours after extubation for cough, sore throat, dysphagia and dysphonia.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal DamageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fred Bulamba, masters, Principal investigator, AnaesthesiologistKintu Andrew, Fellowship, Study chair, LecturerArthur Kwizera, Masters, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294422
- Sponsor's protocol ID
- 2012/HD07/1766U
- Acronym
- LOR-ETCP
- Status last verified
- Jun 2015
- First submitted
- 2 Aug 2014
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Recommended Endotracheal Tube Cuff Pressure; A Randomized Control Trial Comparing Loss of Resistance Syringe to Pilot Balloon Palpation.
- ClinicalTrials.gov ID
- NCT02294422
- Acronym / sponsor ID
- LOR-ETCP / 2012/HD07/1766U
- Conditions
- Tracheal Damage
- Keywords
- Loss of resistance, Pilot balloon, Cuff pressure, Endotracheal tube
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Nov 2014 (estimated)
- 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 aimed at establishing whether use of loss of resistance syringe (LOR) that is traditionally used for identifying epidural space, is a better method for providing safe cuff pressures in adults intubated with cuffed endotracheal tubes. The conventional method is the use of pilot ballon palpation (PBP) to approximate cuff pressures but this is associated with airway damage.
The study hypothesis states that both the loss of resistance syringe method and the pilot balloon palpation methods achieve the recommended endotracheal tube intracuff pressures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2. LOR and aneroid manometer group | Experimental | Device: LOR, Device: Aneroid manometerafter inflating the endotracheal tube (ETT) cuff using a loss of resistance syringe (BD Epillor LOR), the LOR syringe is left attached to the pilot balloon and and any excess pressure will be passively released until the plunger stops drawing back. |
| 1. PBP and aneroid manometer group | Placebo comparator | Device: PBP, Device: Aneroid manometerThe anaesthesia care provider shall inflate the ETT cuff via the pilot balloon with small volumes of air as he/she 'feels ' for the pressures in the pilot balloon to a pressure he/she thinks is just enough. An aneroid manometer (VBM, Germany. Accurate in the range 0-120 cmH2O +-2 cmH2O) shall then be attached by the investigator and measurement of the pressure taken. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American society of anesthesiologists (ASA) physical status classes I-IV
Key exclusion criteria (3 listed)
- Known or anticipated laryngo-tracheal abnormalities.
- Patients with cough, sore throat, dysphagia and dysphonia.
- Patients in whom intubation is attempted more than twice
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 |
|---|---|---|
| PBPAlso: Pilot balloon palpation techniquethe pilot balloon is continuously palpated o felt for adequate pressure as its being inflated. | Device | 1. PBP and aneroid manometer group |
| LORAlso: LOR syinge | Device | 2. LOR and aneroid manometer group |
| Aneroid manometerAlso: VBM, GermanyThe pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge. | Device | 1. PBP and aneroid manometer group, 2. LOR and aneroid manometer group |
Primary outcome
The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O
Time frame: 5minutes
This outcome will be measured within the first 5 minutes after intubation of the patient. The recommended range of intracuff pressure for this study is 20-30cmH2O
1 secondary outcome
Incidence of early postoperative airway symptoms
Time frame: 12 hours
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 30 Jun 2015.
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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.
Fred Bulamba, masters principal investigator
Anaesthesiologist
Kintu Andrew, Fellowship study chair
Lecturer
Arthur Kwizera, Masters study director
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBP, LOR and Aneroid manometer in people with Tracheal Damage, run by Makerere University at 1 site in Uganda.
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 3 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 30 Jun 2015. 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 Uganda. 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. Some participants in this study may receive a placebo. 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?
The percentage of subjects with intracuff pressure ranging from 20cm H2O to 30cmH2O (time frame: 5minutes). 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 30 Jun 2015.