Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02262039
• Collaborator: SurgiQuest, Inc. (Industry)
• Enrollment: 41
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the Airseal System will reduce post-operative pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.

Condition or Disease	Intervention/Treatment	Phase
Pain	Device: Valveless recirculating insufflation (VTI); Device: Conventional pressure	N/A

Detailed Description

Our hypothesis is that Airseal Insufflation System will provide reduced mean operative insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain control and improved operative safety.

The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration. These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and bariatric procedures. The established benefits in a human model provide a foundation for translating this technology to living kidney donors. The advantage lies in the ability to improve pain-related outcomes in this population, which translates into increased living donation; the single solution to reduce mortality for patients suffering from end-stage kidney disease.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System: A Randomized Control Trial
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Pressure Conventional Insufflation with 15mmHg target pressure	Device: Conventional pressure; 15 mmHg target pressure
Experimental: Low Pressure (VTI) Valveless recirculating insufflation (VTI) with 10mmHg target pressure	Device: Valveless recirculating insufflation (VTI); 10 mmHg target pressure

Outcome Measures

Primary Outcome Measures

1. Narcotic Use (mg) [Intra-Operative on day of surgery]

   Total Morphine Equivalents - mean in mg

2. Narcotic Use (mg) [Post-operative (until time of discharge, typically 2-4 days)]

   Total Morphine Equivalents - mean in mg

3. Narcotic Use (mg) [Operative and Post-operative (until time of discharge, typically 2-4 days)]

   Total Morphine Equivalent - mean in mg

Secondary Outcome Measures

1. Subjective Pain Score [1 hour post-op]

   Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.

2. Subjective Pain Score [6 hours post-op]

   Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.

3. Subjective Pain Score [12 hours post-op]

   Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.

4. Mean ETCO2 [intraoperative]

   mean End-tidal carbon dioxide concentration in the expired air

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Any living donor who has been approved to donate a kidney is eligible to participate.

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale New Haven Transplantation Center	New Haven	Connecticut	United States	06520

Sponsors and Collaborators

• Yale University
• SurgiQuest, Inc.

Investigators

• Study Director: Sanjay Kulkarni, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02262039
• Other Study ID Numbers: 1405013985
• First Posted: Oct 10, 2014
• Last Update Posted: Jan 17, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Yale University: living; kidney; donors

Study Results

Participant Flow

Arm/Group Title	Conventional Pressure	Low Pressure (VTI)
Arm/Group Description	15mmHg target pressure	10mmHg target pressure VTI = Valveless recirculating insufflation
Period Title: Overall Study
STARTED	14	27
COMPLETED	14	27
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Conventional Pressure	Low Pressure (VTI)	Total
Arm/Group Description	15mmHg target pressure	10mmHg target pressure VTI= Valveless recirculating insufflation	Total of all reporting groups
Overall Participants	14	27	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.6 (12.3)	51.6 (14.5)	47.6 (13.2)
Sex: Female, Male (Count of Participants)
Female	8 57.1%	16 59.3%	24 58.5%
Male	6 42.9%	11 40.7%	17 41.5%
Race/Ethnicity, Customized (participants) [Number]
White	11 78.6%	22 81.5%	33 80.5%
African American	2 14.3%	2 7.4%	4 9.8%
Hispanic	1 7.1%	3 11.1%	4 9.8%
Nephrectomy Laterality (participants) [Number]
Left	11 78.6%	24 88.9%	35 85.4%
Right	3 21.4%	3 11.1%	6 14.6%
ASA Class (participants) [Number]
1	9 64.3%	17 63%	26 63.4%
2	5 35.7%	10 37%	15 36.6%

Outcome Measures

1. Primary Outcome

Title	Narcotic Use (mg)
Description	Total Morphine Equivalents - mean in mg
Time Frame	Intra-Operative on day of surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Pressure	Low Pressure (VTI)
Arm/Group Description	15mmHg target pressure	10mmHg target pressure VTI= Valveless recirculating insufflation
Measure Participants	14	27
Mean (Standard Deviation) [mg]	113.8 (19)	99.6 (25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Pressure, Low Pressure (VTI)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Narcotic Use (mg)
Description	Total Morphine Equivalents - mean in mg
Time Frame	Post-operative (until time of discharge, typically 2-4 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Pressure	Low Pressure (VTI)
Arm/Group Description	15mmHg target pressure	10mmHg target pressure VTI= Valveless recirculating insufflation
Measure Participants	14	27
Mean (Standard Deviation) [mg]	130.8 (125.6)	134.5 (80.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Pressure, Low Pressure (VTI)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	t-test, 2 sided
	Comments

3. Primary Outcome

Title	Narcotic Use (mg)
Description	Total Morphine Equivalent - mean in mg
Time Frame	Operative and Post-operative (until time of discharge, typically 2-4 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Pressure	Low Pressure (VTI)
Arm/Group Description	15mmHg target pressure	10mmHg target pressure VTI= Valveless recirculating insufflation
Measure Participants	14	27
Mean (Standard Deviation) [mg]	244.6 (126.7)	234.0 (88.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Pressure, Low Pressure (VTI)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.78
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Subjective Pain Score
Description	Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.
Time Frame	1 hour post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Pressure	Low Pressure (VTI)
Arm/Group Description	15mmHg target pressure	10mmHg target pressure VTI= Valveless recirculating insufflation
Measure Participants	14	27
Mean (Standard Deviation) [units on a scale]	4.6 (3.2)	5.3 (3.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Pressure, Low Pressure (VTI)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Subjective Pain Score
Description	Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.
Time Frame	6 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Pressure	Low Pressure (VTI)
Arm/Group Description	15mmHg target pressure	10mmHg target pressure VTI= Valveless recirculating insufflation
Measure Participants	14	27
Mean (Standard Deviation) [units on a scale]	3.5 (3.2)	4.6 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Pressure, Low Pressure (VTI)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Subjective Pain Score
Description	Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.
Time Frame	12 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Pressure	Low Pressure (VTI)
Arm/Group Description	15mmHg target pressure	10mmHg target pressure VTI= Valveless recirculating insufflation
Measure Participants	14	27
Mean (Standard Deviation) [units on a scale]	3.9 (3.0)	3.7 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Pressure, Low Pressure (VTI)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.82
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Mean ETCO2
Description	mean End-tidal carbon dioxide concentration in the expired air
Time Frame	intraoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Conventional Pressure	Low Pressure (VTI)
Arm/Group Description	15mmHg target pressure	10mmHg target pressure VTI= Valveless recirculating insufflation
Measure Participants	14	27
Mean (Standard Deviation) [mmHg]	29.7 (4.4)	30.8 (3.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Conventional Pressure, Low Pressure (VTI)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	1 month
Adverse Event Reporting Description	Systematic chart reviews were conducted
Arm/Group Title	Conventional Pressure		Low Pressure (VTI)
Arm/Group Description	15mmHg target pressure		10mmHg target pressure VTI= Valveless recirculating insufflation
All Cause Mortality
	Conventional Pressure		Low Pressure (VTI)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Conventional Pressure		Low Pressure (VTI)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Conventional Pressure		Low Pressure (VTI)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/14 (21.4%)		2/27 (7.4%)
Infections and infestations
Urinary tract infection	1/14 (7.1%)	1	0/27 (0%)	0
Wound infection	0/14 (0%)	0	2/27 (7.4%)	2
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia	1/14 (7.1%)	1	0/27 (0%)	0
Surgical and medical procedures
Post-operative hemorrhage	1/14 (7.1%)	1	0/27 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.