MTPI for Anaesthesia therapy

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
The University of Texas Health Science Center at Houston, Houston, TX
Anaesthesia therapy
MTPI - Drug
Eligibility
18+
All Sexes
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Study Summary

The purpose of this study is to assess and compare the conditions for tracheal intubation obtained with Modified Time Principle Induction (MTPI) and that obtained with classic induction (CI). This study will compare the efficiency of tracheal intubation with the two induction techniques, as well as evaluate for potential adverse events.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 17 Secondary · Reporting Duration: during surgery

Between laryngoscope insertion to onset of ventilation (less than 7 minutes)
The total time between laryngoscope insertion into mouth and the onset of ventilation after tracheal intubation
after 3 failed intubation attempts (less than 7 minutes from start of intubation)
Number of participants for whom tracheal intubations failed
after 5 minutes of successful ventilation
Number of participants for whom tracheal intubations were successful on the first attempt
Number of times tracheal intubations are attempted
during surgery
Physical response during intubation, as assessed by the number of participants who coughed
Physical response during intubation, as assessed by the number of participants who moved
from start of induction to 5 minutes of successful ventilation
Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)
from the start of induction drug administration to about 5 minutes after successful ventilation
Diastolic blood pressure
End-tidal carbon dioxide (CO2) level
Heart Rate
Oxygen saturation (SpO2)
Systolic blood pressure
Hour 24
Number of participants that had injury associated with intubation
within one hour after surgery
Number of participants who had Awareness of muscle paralysis before loss of consciousness as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Number of participants who had nausea and vomiting as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Number of participants who had presence of Sore throat as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Number of participants who had recollection of pain on induction
Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Classic Induction group
1 of 2
MTPI group
1 of 2
Active Control
Experimental Treatment

143 Total Participants · 2 Treatment Groups

Primary Treatment: MTPI · No Placebo Group · Phase 4

MTPI group
Drug
Experimental Group · 1 Intervention: MTPI · Intervention Types: Drug
Classic Induction group
Drug
ActiveComparator Group · 1 Intervention: Classic Induction · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during surgery
Closest Location: The University of Texas Health Science Center at Houston · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2008First Recorded Clinical Trial
1 TrialsResearching Anaesthesia therapy
190 CompletedClinical Trials

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
785 Previous Clinical Trials
245,400 Total Patients Enrolled
1 Trials studying Anaesthesia therapy
100 Patients Enrolled for Anaesthesia therapy
Lauren M Nakazawa, MD, MBAPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.