Ventilation Therapy; ComplicationsNCT05005390

Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway

A study testing TTIP ventilation and Mask Ventilation in people with Ventilation Therapy; Complications, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the efficacy of TTIP-first ventilation and to compare the efficacy of TTIP first ventilation with the current practice of mask-first ventilation Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventilation Therapy; Complications
What is being tested?: TTIP ventilation and Mask Ventilation
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 147 participants
Where: 1 siteUnited States
Study dates: 26 Jul 2021to 17 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

BMI >30 kg/m2
Mallampati class III or IV
Requiring general anesthesia

Who cannot join

Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease(COPD)and asthma
American Society of Anesthesiologists (ASA)physical status classification ≥IV
Emergency surgery
Induction requiring rapid sequence for intubation
Patients requiring awake intubation
Pregnant women
Untreated ischemic heart disease
Contraindication for mask ventilation

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway:A Prospective Randomized and Blinded Trial.

The purpose of this study is to determine the efficacy of TTIP-first ventilation and to compare the efficacy of TTIP first ventilation with the current practice of mask-first ventilation

Conditions: Ventilation Therapy; Complications
Being tested: TTIP ventilation, Mask Ventilation
Keywords: Bag Mask Ventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TTIP ventilationDevice
In TTIP ventilation, an endotracheal tube is inserted via the nostril or oral cavity and subsequently advanced until the tip of the tube reaches approximately the level of the glottis.
Mask VentilationDevice
In mask ventilation, a mask is placed over the nose and mouth.

Study groups in NCT05005390
Study group	Role	What they receive
TTIP ventilation, then mask ventilation	Experimental	Subjects will first be ventilated with the TTIP technique. If the subjects are adequately ventilated, as defined by carbon dioxide measured during exhalation in at least one of the first three consecutive breaths, ventilation will continue until completion of 10 breaths, for 1 min (Step 1). Subjects will then be ventilated with mask ventilation (Step 2). In Step 1, if ventilation fails with the TTIP technique for all of the first three consecutive breaths, the subject will be crossed over to the mask ventilation. If ventilation fails again with all the first three consecutive breaths after crossover, the study will be terminated. The routine care is resumed including tracheal intubation or laryngeal mask airway (LMA) insertion. Receives: Device: TTIP ventilation; Device: Mask Ventilation
Mask ventilation, then TTIP ventilation	Active comparator	Subjects will first be ventilated with the mask technique. If the subjects are adequately ventilated, as defined by carbon dioxide measured during exhalation in at least one of the first three consecutive breaths, ventilation will continue until completion of 10 breaths, for 1 min (Step 1). Subjects will then be ventilated with TTIP technique (Step 2). In Step 1, if ventilation fails for all of the first three consecutive breaths, the subject will be crossed over to the TTIP ventilation. If ventilation fails again with all the first three consecutive breaths after crossover, the study will be terminated. The routine care is resumed including tracheal intubation or LMA insertion. Receives: Device: TTIP ventilation; Device: Mask Ventilation

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Successful Ventilation
Successful ventilation is defined as expired carbon dioxide with three phases in at least one of the first three consecutive breaths.
Measured: from start of ventilation to end of ventilation (about 1 minute)

Secondary outcomes (5)

Expired Tidal Volume of Ventilation
This is measured by readings from the ventilator used in the operating room
Measured: from start of ventilation to end of ventilation (about 1 minute)
Peak Inspiratory Airway Pressure Achieved
This is measured by readings from the ventilator used in the operating room
Measured: from start of ventilation to end of ventilation (about 1 minute)
Dynamic Airway Resistance
This is defined as the peak inspiratory flow divided by the corresponding airway pressure.
Measured: from start of ventilation to end of ventilation (about 1 minute)
Satisfaction of the Providers Obtained With Post Ventilation Survey
Measured: Baseline before start of surgery
Satisfaction of the Providers Obtained With Post Ventilation Survey
Measured: end of surgery (about 1 hour after start)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 202117 Nov 2022

First posted13 Aug 2021
Study start26 Jul 2021
Primary completion17 Nov 2022
Study completion17 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ventilation Therapy; ComplicationsStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
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: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05005390
Sponsor's protocol ID: HSC-MS-21-0478
Status last verified: Jan 2024
First submitted: 6 Aug 2021
Last updated: 24 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway:A Prospective Randomized and Blinded Trial.
ClinicalTrials.gov ID: NCT05005390
Acronym / sponsor ID: HSC-MS-21-0478
Conditions: Ventilation Therapy; Complications
Keywords: Bag Mask Ventilation
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 26 Jul 2021 (actual)
Primary completion: 17 Nov 2022 (actual)
Study completion: 17 Nov 2022 (actual)
First posted: 13 Aug 2021 (actual)
Results: Posted 24 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the efficacy of TTIP-first ventilation and to compare the efficacy of TTIP first ventilation with the current practice of mask-first ventilation

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TTIP ventilation, then mask ventilation	Experimental	Device: TTIP ventilation, Device: Mask VentilationSubjects will first be ventilated with the TTIP technique. If the subjects are adequately ventilated, as defined by carbon dioxide measured during exhalation in at least one of the first three consecutive breaths, ventilation will continue until completion of 10 breaths, for 1 min (Step 1). Subjects will then be ventilated with mask ventilation (Step 2). In Step 1, if ventilation fails with the TTIP technique for all of the first three consecutive breaths, the subject will be crossed over to the mask ventilation. If ventilation fails again with all the first three consecutive breaths after crossover, the study will be terminated. The routine care is resumed including tracheal intubation or laryngeal mask airway (LMA) insertion.
Mask ventilation, then TTIP ventilation	Active comparator	Device: TTIP ventilation, Device: Mask VentilationSubjects will first be ventilated with the mask technique. If the subjects are adequately ventilated, as defined by carbon dioxide measured during exhalation in at least one of the first three consecutive breaths, ventilation will continue until completion of 10 breaths, for 1 min (Step 1). Subjects will then be ventilated with TTIP technique (Step 2). In Step 1, if ventilation fails for all of the first three consecutive breaths, the subject will be crossed over to the TTIP ventilation. If ventilation fails again with all the first three consecutive breaths after crossover, the study will be terminated. The routine care is resumed including tracheal intubation or LMA insertion.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

BMI >30 kg/m2
Mallampati class III or IV
Requiring general anesthesia

Key exclusion criteria (8 listed)

Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease(COPD)and asthma
American Society of Anesthesiologists (ASA)physical status classification ≥IV
Emergency surgery
Induction requiring rapid sequence for intubation
Patients requiring awake intubation

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
TTIP ventilationIn TTIP ventilation, an endotracheal tube is inserted via the nostril or oral cavity and subsequently advanced until the tip of the tube reaches approximately the level of the glottis.	Device	Mask ventilation, then TTIP ventilation, TTIP ventilation, then mask ventilation
Mask VentilationIn mask ventilation, a mask is placed over the nose and mouth.	Device	Mask ventilation, then TTIP ventilation, TTIP ventilation, then mask ventilation

Primary outcome

Number of Patients With Successful Ventilation
Time frame: from start of ventilation to end of ventilation (about 1 minute)
Successful ventilation is defined as expired carbon dioxide with three phases in at least one of the first three consecutive breaths.

5 secondary outcomes

Expired Tidal Volume of Ventilation
Time frame: from start of ventilation to end of ventilation (about 1 minute)
Peak Inspiratory Airway Pressure Achieved
Time frame: from start of ventilation to end of ventilation (about 1 minute)
Dynamic Airway Resistance
Time frame: from start of ventilation to end of ventilation (about 1 minute)
Satisfaction of the Providers Obtained With Post Ventilation Survey
Time frame: Baseline before start of surgery
Satisfaction of the Providers Obtained With Post Ventilation Survey
Time frame: end of surgery (about 1 hour after start)

Results and safety

Results posted to the registry on 24 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TTIP Ventilation, Then Mask Ventilation	76	57
Mask Ventilation, Then TTIP Ventilation	71	50

Primary outcome: Number of Patients With Successful Ventilation

Time frame: from start of ventilation to end of ventilation (about 1 minute). Count of participants. Unit: Participants

Measure	TTIP Ventilation n = 136	Mask Ventilation n = 136
Value	127	115

Population analysed: Data were not collected for 11 participants in the TTIP Ventilation arm and the Mask ventilation arm.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: during time in PACU (about 30 minutes to 2 hours). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TTIP Ventilation	0 of 147 (0%)	0 of 147 (0%)	0 of 147
Mask Ventilation	0 of 147 (0%)	0 of 147 (0%)	0 of 147

Limitations and caveats (from the sponsor): We calculated the sample size based on a parallel study design that resulted in a sample size of 245. We later performed a sample size calculation based on a crossover study design and realized that by enrolling one hundred forty-seven patients, we would achieve greater than 80% power for our primary analysis to detect a significant difference between the techniques with type I error (α) \< 0.05, even with a possible 10% dropout. Therefore, we terminated our study with 147 patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
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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.

Travis Markham, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TTIP ventilation and Mask Ventilation in people with Ventilation Therapy; Complications, run by The University of Texas Health Science Center, Houston at 1 site in United States.

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 3 inclusion and 8 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 24 Jan 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 24 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients With Successful Ventilation (time frame: from start of ventilation to end of ventilation (about 1 minute)). 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 NCT05005390.

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 24 Jan 2024.