Trial Outcomes & Findings for The Effect of Povidone-iodine Ophthalmic Surgical Prep Solution on Respiration in Children Undergoing Strabismus Surgery With General Anesthesia. (NCT NCT03349515)

Last Updated: 2019-09-16

Results Overview

The iPhone stopwatch application will be used and its 'lap button' feature to collect the respiration peak intervals (in seconds) for 5 breaths. Specifically, at the patient's peak inspiration (as seen on the capnography), the study member will start the stopwatch and proceed to hit the 'lap' button for the next 5 consecutive inspiration peaks. These data intervals will be recorded on the data sheet after the 5 breaths are over, as the intervals are conveniently stored and numbered below the stopwatch in the app

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

106 participants

Primary outcome timeframe

5 minutes

Results posted on

2019-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Group A - Povidone-iodine Ophthalmic Solution. Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first. The eye drops will be administered by the study anesthesiologist.	Group B - Ophthalmic Balanced Salt Solution. Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.
Overall Study STARTED	55	51
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A - Povidone-iodine Ophthalmic Solution. Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first. The eye drops will be administered by the study anesthesiologist.	Group B - Ophthalmic Balanced Salt Solution. Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.
Overall Study Lack of Efficacy	2	0
Overall Study Physician Decision	3	1

Baseline Characteristics

There were 6 patients withdrawn. 5 from Group A and 1 from Group B

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 5 minutes

Outcome measures

Outcome measures
Measure	Group A - Povidone-iodine Ophthalmic Solution. n=50 Participants Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first. The eye drops will be administered by the study anesthesiologist. After application of either solution to the eyes of the patient, any change in ventilation can be detected and timed by observation of the capnography (end-tidal carbon dioxide) and direct observation of the chest wall with use of the iPhone stopwatch feature again. The capnograph is a standard monitor of respiration used during the administration of general anesthesia. Data collected at this time will include whether or not there was a change in respiration, what this change in respiration was, if assisted ventilation was required, how long assisted ventilation was required (if applicable), HR, BP, RR, SaO2 , ETCO2, InspSevo, and ExpSevo. This study intervention and data collection will take less than 5 minutes.	Group B - Ophthalmic Balanced Salt Solution. n=50 Participants Group B will receive three drops in each eye of ophthalmic balanced salt solution.: Group B will receive three drops in each eye of ophthalmic balanced salt solution. The eye drops will be administered by the study anesthesiologist. After application of either solution to the eyes of the patient, any change in ventilation can be detected and timed by observation of the capnography (end-tidal carbon dioxide) and direct observation of the chest wall with use of the iPhone stopwatch feature again. The capnograph is a standard monitor of respiration used during the administration of general anesthesia. Data collected at this time will include whether or not there was a change in respiration, what this change in respiration was, if assisted ventilation was required, how long assisted ventilation was required (if applicable), HR, BP, RR, SaO2 , ETCO2, InspSevo, and ExpSevo. This study intervention and data collection will take less than 5 minutes
Breath Duration Breath 1	2.14 seconds Standard Error 0.621	2.18 seconds Standard Error 0.626
Breath Duration Breath 2	2.26 seconds Standard Error 0.621	2.15 seconds Standard Error 0.626
Breath Duration Breath 3	5.02 seconds Standard Error 0.621	2.18 seconds Standard Error 0.626
Breath Duration Breath 4	5.65 seconds Standard Error 0.621	2.23 seconds Standard Error 0.626
Breath Duration Breath 5	3.08 seconds Standard Error 0.621	2.22 seconds Standard Error 0.626
Breath Duration Breath 6	7.47 seconds Standard Error 0.621	2.25 seconds Standard Error 0.626
Breath Duration Breath 7	3.22 seconds Standard Error 0.621	2.20 seconds Standard Error 0.626
Breath Duration Breath 8	2.49 seconds Standard Error 0.621	2.17 seconds Standard Error 0.626
Breath Duration Breath 9	2.69 seconds Standard Error 0.621	2.21 seconds Standard Error 0.626
Breath Duration Breath 10	2.49 seconds Standard Error 0.621	2.15 seconds Standard Error 0.626
Breath Duration Breath 11	2.35 seconds Standard Error 0.621	2.2 seconds Standard Error 0.626
Breath Duration Breath 12	2.15 seconds Standard Error 0.621	2.17 seconds Standard Error 0.626
Breath Duration Breath 13	2.12 seconds Standard Error 0.621	2.16 seconds Standard Error 0.626
Breath Duration Breath 14	2.14 seconds Standard Error 0.621	2.18 seconds Standard Error 0.626
Breath Duration Breath 15	2.09 seconds Standard Error 0.621	2.09 seconds Standard Error 0.626

Adverse Events

Group A - Povidone-iodine Ophthalmic Solution.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B - Ophthalmic Balanced Salt Solution.

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

Dr. Michelle Rovner

Medical University of South Carolina

Phone: 843-792-2322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group A - Povidone-iodine Ophthalmic Solution. n=50 Participants Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first.	Group B - Ophthalmic Balanced Salt Solution. n=50 Participants Group B will receive three drops in each eye of ophthalmic balanced salt solution, with the right eye to receive the drops first.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	50 Participants n=5 Participants • There were 6 patients withdrawn. 5 from Group A and 1 from Group B	50 Participants n=7 Participants • There were 6 patients withdrawn. 5 from Group A and 1 from Group B	100 Participants n=5 Participants • There were 6 patients withdrawn. 5 from Group A and 1 from Group B
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants • There were 6 patients withdrawn. 5 from Group A and 1 from Group B	0 Participants n=7 Participants • There were 6 patients withdrawn. 5 from Group A and 1 from Group B	0 Participants n=5 Participants • There were 6 patients withdrawn. 5 from Group A and 1 from Group B
Age, Categorical >=65 years	0 Participants n=5 Participants • There were 6 patients withdrawn. 5 from Group A and 1 from Group B	0 Participants n=7 Participants • There were 6 patients withdrawn. 5 from Group A and 1 from Group B	0 Participants n=5 Participants • There were 6 patients withdrawn. 5 from Group A and 1 from Group B
Age, Continuous	6.2 years STANDARD_DEVIATION 3.9 • n=5 Participants • There were 6 participants withdrawn. 5 from Group A and 1 from Group B.	6.4 years STANDARD_DEVIATION 3.4 • n=7 Participants • There were 6 participants withdrawn. 5 from Group A and 1 from Group B.	6.31 years STANDARD_DEVIATION 3.61 • n=5 Participants • There were 6 participants withdrawn. 5 from Group A and 1 from Group B.
Sex: Female, Male Female	33 Participants n=5 Participants • There were 6 participants withdrawn. 5 from Group A and 1 from Group B.	27 Participants n=7 Participants • There were 6 participants withdrawn. 5 from Group A and 1 from Group B.	60 Participants n=5 Participants • There were 6 participants withdrawn. 5 from Group A and 1 from Group B.
Sex: Female, Male Male	17 Participants n=5 Participants • There were 6 participants withdrawn. 5 from Group A and 1 from Group B.	23 Participants n=7 Participants • There were 6 participants withdrawn. 5 from Group A and 1 from Group B.	40 Participants n=5 Participants • There were 6 participants withdrawn. 5 from Group A and 1 from Group B.
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.	2 Participants n=7 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.	5 Participants n=5 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=5 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.	48 Participants n=7 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.	95 Participants n=5 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.	0 Participants n=7 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.	0 Participants n=5 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	0 Participants n=7 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	0 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.
Race (NIH/OMB) Asian	1 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	0 Participants n=7 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	1 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	0 Participants n=7 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	0 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	12 Participants n=7 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	20 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.
Race (NIH/OMB) White	38 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	35 Participants n=7 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	73 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	0 Participants n=7 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	0 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	3 Participants n=7 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.	6 Participants n=5 Participants • There were 6 participants that were withdrawn. 5 from Group A and 1 from Group B.
Region of Enrollment United States	50 participants n=5 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.	50 participants n=7 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.	100 participants n=5 Participants • There were 6 participants withdrawn from the study. 5 from Group A and 1 from Group B.