Trial Outcomes & Findings for A Study Comparing Time to Intubate With and Without a Barrier Box (NCT NCT04411056)

NCT ID: NCT04411056

Last Updated: 2025-01-22

Results Overview

Time to intubate refers to the time it takes to insert a tube into a patient's trachea to help them breathe. Intubation is a procedure routinely used before surgery to help keep the airway open. The study will compare the time to intubate in two groups, barrier box and no barrier box. In medical terms, time to intubate is the time from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 78 participants
• Primary outcome timeframe: up to 2 minutes during intubation before surgery
• Results posted on: 2025-01-22

Participant Flow

Participant milestones

Measure	Barrier Box Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box Participants will have routine intubation with no barrier box
Overall Study STARTED	39	39
Overall Study COMPLETED	38	38
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Barrier Box Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box Participants will have routine intubation with no barrier box
Overall Study surgery cancelled	1	0
Overall Study Equipment problem during intubation	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Barrier Box n=38 Participants Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box n=38 Participants Participants will have routine intubation with no barrier box	Total n=76 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 16.7 • n=38 Participants	52.7 years STANDARD_DEVIATION 18.9 • n=38 Participants	55.2 years STANDARD_DEVIATION 17.8 • n=76 Participants
Sex: Female, Male Female	19 Participants n=38 Participants	18 Participants n=38 Participants	37 Participants n=76 Participants
Sex: Female, Male Male	19 Participants n=38 Participants	20 Participants n=38 Participants	39 Participants n=76 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	38 participants n=38 Participants	38 participants n=38 Participants	76 participants n=76 Participants
American Society of Anesthesiology (ASA) Physical Status ASA 1	1 Participants n=38 Participants	2 Participants n=38 Participants	3 Participants n=76 Participants
American Society of Anesthesiology (ASA) Physical Status ASA 2	21 Participants n=38 Participants	25 Participants n=38 Participants	46 Participants n=76 Participants
American Society of Anesthesiology (ASA) Physical Status ASA 3	16 Participants n=38 Participants	11 Participants n=38 Participants	27 Participants n=76 Participants

PRIMARY outcome

Timeframe: up to 2 minutes during intubation before surgery

Time to intubate refers to the time it takes to insert a tube into a patient's trachea to help them breathe. Intubation is a procedure routinely used before surgery to help keep the airway open. The study will compare the time to intubate in two groups, barrier box and no barrier box. In medical terms, time to intubate is the time from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end tidal carbon dioxide.

Outcome measures

Measure	Barrier Box n=38 Participants Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box n=38 Participants Participants will have routine intubation with no barrier box
Time to Intubate	52.1 seconds Interval 26.1 to 78.0	42.0 seconds Interval 19.2 to 64.8

SECONDARY outcome

Timeframe: up to 2 minutes during intubation before surgery

All participants were intubated successfully on the first attempt.

Outcome measures

Measure	Barrier Box n=38 Participants Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box n=38 Participants Participants will have routine intubation with no barrier box
Intubation in First Attempt	38 Participants	38 Participants

SECONDARY outcome

Timeframe: up to 5 minutes

During induction time, there were no patients who needed bag mask ventilation. Bag mask ventilation is a technique used to provide oxygen and ventilation to patients who are not breathing adequately. Induction is the process of transitioning a patient from consciousness to unconsciousness at the beginning of a general anesthetic. The induction time is defined in medical terms as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.

Outcome measures

Measure	Barrier Box n=38 Participants Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box n=38 Participants Participants will have routine intubation with no barrier box
Need for Bag Mask Ventilation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 5 minutes

During process of inserting a tube in a patient's trachea (intubation) before surgery and the process of being given anesthesia (induction), there is a point where a patient's blood oxygen level drops to its lowest point during the process. This is referred to as the lowest oxygen saturation. In medical terms this is the lowest peripheral capillary oxygen saturation during the induction time defined as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.

The maximum blood oxygen level is 100%. Normal range is 95% - 100%. Low oxygen level (hypoxemia)is below 95%.

Outcome measures

Measure	Barrier Box n=38 Participants Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box n=38 Participants Participants will have routine intubation with no barrier box
Participants' Lowest Blood Oxygen Level (Lowest Oxygen Saturation During Induction and Intubation)	98.7 percentage of blood oxygen Standard Deviation 2.6	98.8 percentage of blood oxygen Standard Deviation 2.6

SECONDARY outcome

Timeframe: up to 5 minutes

Induction is the process of transitioning a patient from consciousness to unconsciousness at the beginning of a general anesthetic. The induction time is defined in medical terms as the time taken from propofol bolus to loss of twitches measured with a peripheral nerve stimulator.

Outcome measures

Measure	Barrier Box n=38 Participants Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box n=38 Participants Participants will have routine intubation with no barrier box
Induction Time	65.9 seconds Interval 39.2 to 92.6	67.7 seconds Interval 43.7 to 91.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 minutes

Airway assessment by Mallampati score (scale of 0 to 4) used to assess and prepare for possible difficult intubation of participants who score high. Lower scores are less likely to have a difficult intubation and higher scores are more likely to have a difficult intubation.

Mallampati 0: Any part of the epiglottis is visible Mallampati 1: soft palate, uvula, and pillars are visible Mallampati 2: soft palate and uvula are visible Mallampati 3: only the soft palate and base of the uvula are visible Mallampati 4: only the hard palate is visible.

Outcome measures

Measure	Barrier Box n=38 Participants Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box n=38 Participants Participants will have routine intubation with no barrier box
Airway Assessment by Mallampati Score (Scale of 0 to 4) Mallampati 0	0 Participants	0 Participants
Airway Assessment by Mallampati Score (Scale of 0 to 4) Mallampati 1	3 Participants	3 Participants
Airway Assessment by Mallampati Score (Scale of 0 to 4) Mallampati 2	29 Participants	31 Participants
Airway Assessment by Mallampati Score (Scale of 0 to 4) Mallampati 3	6 Participants	4 Participants
Airway Assessment by Mallampati Score (Scale of 0 to 4) Mallampati 4	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 minutes

Thyromental Distance (TMD) is the distance from the thyroid notch to the chin when the head is extended. TMD is used to assess and prepare for possible difficult intubation. A distance of greater than 3 finger breadth may be less likely to have a difficult intubation. A distance less than or equal to 3 finger breadth may be more likely to have a difficult intubation.

Number of participants with TMD greater than 3 finger breadth will be assessed in both groups (Barrier Box and No Barrier Box).

Outcome measures

Measure	Barrier Box n=38 Participants Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box n=38 Participants Participants will have routine intubation with no barrier box
Airway Assessment by Thyromental Distance (TMD) TMD greater than 3 finger breadth	38 Participants	38 Participants
Airway Assessment by Thyromental Distance (TMD) TMD less than or equal to 3 finger breadth	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 minutes

Inter incisor distance is the distance between the upper and lower teeth of the open mouth of a patient. Inter incisor distance is used to assess and prepare for possible difficult intubation of participants who are less than or equal to 3 finger breadth. A distance greater than 3 finger breadth may be less likely to have a difficult airway or airway constriction.

Number of participants with Inter incisor distance greater than 3 finger breadth will be assessed in both groups (Barrier Box and No Barrier Box).

Outcome measures

Measure	Barrier Box n=38 Participants Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box n=38 Participants Participants will have routine intubation with no barrier box
Airway Assessment by Inter Incisor Distance Inter incisor distance less than or equal to 3 finger breadth	0 Participants	0 Participants
Airway Assessment by Inter Incisor Distance Inter incisor distance greater than 3 finger breadth	38 Participants	38 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 minutes

Neck range of motion is the degree of movement in the neck - how much the head can flex (bend forward), extend (tilt backwards), and rotate side to side. Neck range of motion helps assess and prepare for possible difficult intubation. Full range of motion is less likely for a difficult intubation. Restricted range of motion indicates a possible difficult intubation.

Number of patients with Neck range of motion (categorized as full or restricted) will be assessed in both groups (Barrier Box and No Barrier Box)

Outcome measures

Measure	Barrier Box n=38 Participants Participants will have a barrier box placed during intubation Barrier box: Placement of barrier box ( a plastic box for shielding)	No Barrier Box n=38 Participants Participants will have routine intubation with no barrier box
Neck Range of Motion Full	36 Participants	38 Participants
Neck Range of Motion Restricted	2 Participants	0 Participants

Adverse Events

Barrier Box

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Barrier Box

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Praneet Madabhushi MD

The Guthrie Clinic

Phone: 5708874882

Email: praneeth.madabhushi@guthrie.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place