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Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship During Laparoscopic Surgery

Primary Purpose

Anesthesia, General/Methods, Laparoscopy, Respiration, Artificial

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Standard PEEP ventilation
Matched PEEP ventilation
Sponsored by
Hospital Universitario La Fe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anesthesia, General/Methods focused on measuring Mechanical ventilation, Driving Pressure, Protective Lung VEntilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiology (ASA) risk scale I to III
  • Age > 18 years
  • Previously signed informed consent
  • Undergoing laparoscopic surgery

Exclusion Criteria:

  • ASA ≥ IV
  • Pregnancy
  • Advanced liver, kidney or cardiopulmonary disease

Sites / Locations

  • Hospital Universitario La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard PEEP ventilation

Matched PEEP Ventilation

Arm Description

During pneumoeperitoneum insufflation the patient is ventilated with 7 ml/kg per ideal body weight, inspiration:expiration (I:E) ratio 1:2, and respiration rate (RR) to maintain EtCO2 at 35-38 mmHg and 5 cmH20 of PEEP at every intra-abdominal pressure (IAP) step (8, 12 and 15 mmHg).

During pneumoeperitoneum insufflation the patient is ventilated with 7 ml/kg per ideal body weight, inspiration:expiration (I:E) ratio 1:2, and respiration rate (RR) to maintain EtCO2 at 35-38 mmHg and a level of PEEP matched to every IAP step (8, 12 and 15 mmHg). 1 mmHg = 1,36 cmH20. Between the standard and matched PEEP intervention there is a washout period that with a recruitment maneuver to re-establish baseline lung condition.

Outcomes

Primary Outcome Measures

Transpulmonary driving pressure (TpDp) difference between standard and matched PEEP ventilation
TpDp (assessed in centimeters of water, cmH20) as assessed by ventilatory pressure and pleural pressure (recorded by an esophageal probe) is recorded at every intra-abdominal pressure level during pneumoperitoneum insufflation. The primary outcome is the difference between a standard perioperative management (fixed PEEP + 15 mmHg pneumoperitoneum pressure) and matched PEEP to intra-abdominal pressure and 8mmHg intra-abdominal pressure

Secondary Outcome Measures

Transpulmonary driving pressure and intra-abdmominal pressure relationship (multivariate adaptive linear regression)
TpDp (in cmH20) is recorded at different levels of IAP and with two different PEEP settings (in cmH20; two levels are: fixed at each IAP level, standard group and matched at each IAP level, matched group). The relationship between TpDp and IAP (both treated as continuous variables) at each PEEP level is plotted and a multiadaptive linear regression is fitted.
Transpulmonary driving pressure and respiratory driving pressure (RDp) relationship (multivariate adaptive linear regression).
Respiratory driving pressure (transpulmonary driving pressure + pressure to move the chest wall, in cmH20, RpDp) and TpDp relationship at each IAP and PEEP level will be assessed. The relationship between TpDp and RpDp (both treated as continuous variables) at each PEEP level is plotted and a multiadaptive linear regression is fitted.
Respiratory system compliance (Crs) difference between standard and matched PEEP levels
Respiratory system compliance measures the system's ability to stretch. It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20)
Pulmonary compliance (Cp) difference
Respiratory system compliance measures the system's ability to stretch (ml/cmH20). It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20). By using an esophageal probe measurement the two can be partitioned and analyzed separately.
Chest wall compliance (CCw) difference
Respiratory system compliance measures the system's ability to stretch (ml/cmH20). It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20). By using an esophageal probe measurement the two can be partitioned and analyzed separately.
Pulmonary Stress index difference
Stress index is based on respiratory pressure curve analysis and assess whether the lungs are overdistended or collapsed

Full Information

First Posted
January 30, 2018
Last Updated
December 14, 2019
Sponsor
Hospital Universitario La Fe
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1. Study Identification

Unique Protocol Identification Number
NCT03435913
Brief Title
Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship During Laparoscopic Surgery
Official Title
Assessment of Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship at Different Levels of Positive End-expiratory Pressure (PEEP) During Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Fe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: The aim of this project is to evaluate how intra-abdominal pressure paired coupled with different ventilatory positive end-expiratory pressure levels affects the transpulmonary driving pressure during pneumoperiteneum insufflation for laparoscopic surgery. Methodology: Patients undergoing laparoscopic surgery will be included. The study will investigate the relationship between intra-abdominal pressure (IAP) and transpulmonary driving pressure (TpDp) and the effect of titration of PEEP on their relationship. At three different levels of intra-abdominal pressure, the respiratory driving pressure (RDp) and TpDp in each subject will be measured in each subject. The same subject will undergo two different ventilation strategies. Demographic data (height, weight, body mass index and sex), ASA physical status (surgical risk classification of the American Society of Anesthesiology), number of previous abdominal surgeries, number of previous pregnancies, and respiratory comorbidities will be collected. Respiratory pressures and mechanics will be recorded at each level of intra-abdominal pressure (IAP) during each ventilatory strategy. The variables recorded will include: airway pressures (Plateau pressure Pplat, Peak pressure, Ppeak), the final esophageal pressure of inspiration and expiration and pulmonary stress index. Mixed linear regression will be used to evaluate the relationship between different PEEP levels, IAP and TpDp by adjusting for known confounders and adding individuals as a random factor. Likewise, an analysis using a mixed linear regression model with the pulmonary stress index as a function of the intra-abdominal pressure, the ventilation regime, and a specific random intercept term for each subject will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, General/Methods, Laparoscopy, Respiration, Artificial, Positive-Pressure Respiration, End-Expiratory Pressure, Positive, Ventilator-Induced Lung Injury
Keywords
Mechanical ventilation, Driving Pressure, Protective Lung VEntilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard PEEP ventilation
Arm Type
Experimental
Arm Description
During pneumoeperitoneum insufflation the patient is ventilated with 7 ml/kg per ideal body weight, inspiration:expiration (I:E) ratio 1:2, and respiration rate (RR) to maintain EtCO2 at 35-38 mmHg and 5 cmH20 of PEEP at every intra-abdominal pressure (IAP) step (8, 12 and 15 mmHg).
Arm Title
Matched PEEP Ventilation
Arm Type
Experimental
Arm Description
During pneumoeperitoneum insufflation the patient is ventilated with 7 ml/kg per ideal body weight, inspiration:expiration (I:E) ratio 1:2, and respiration rate (RR) to maintain EtCO2 at 35-38 mmHg and a level of PEEP matched to every IAP step (8, 12 and 15 mmHg). 1 mmHg = 1,36 cmH20. Between the standard and matched PEEP intervention there is a washout period that with a recruitment maneuver to re-establish baseline lung condition.
Intervention Type
Other
Intervention Name(s)
Standard PEEP ventilation
Intervention Description
During mechanical ventilation a fixed PEEP (5 mcH2O) is set at all IAP levels during pneumoperitoneum insufflation
Intervention Type
Other
Intervention Name(s)
Matched PEEP ventilation
Intervention Description
During mechanical ventilation PEEP is matched to IAP level
Primary Outcome Measure Information:
Title
Transpulmonary driving pressure (TpDp) difference between standard and matched PEEP ventilation
Description
TpDp (assessed in centimeters of water, cmH20) as assessed by ventilatory pressure and pleural pressure (recorded by an esophageal probe) is recorded at every intra-abdominal pressure level during pneumoperitoneum insufflation. The primary outcome is the difference between a standard perioperative management (fixed PEEP + 15 mmHg pneumoperitoneum pressure) and matched PEEP to intra-abdominal pressure and 8mmHg intra-abdominal pressure
Time Frame
Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Secondary Outcome Measure Information:
Title
Transpulmonary driving pressure and intra-abdmominal pressure relationship (multivariate adaptive linear regression)
Description
TpDp (in cmH20) is recorded at different levels of IAP and with two different PEEP settings (in cmH20; two levels are: fixed at each IAP level, standard group and matched at each IAP level, matched group). The relationship between TpDp and IAP (both treated as continuous variables) at each PEEP level is plotted and a multiadaptive linear regression is fitted.
Time Frame
Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Title
Transpulmonary driving pressure and respiratory driving pressure (RDp) relationship (multivariate adaptive linear regression).
Description
Respiratory driving pressure (transpulmonary driving pressure + pressure to move the chest wall, in cmH20, RpDp) and TpDp relationship at each IAP and PEEP level will be assessed. The relationship between TpDp and RpDp (both treated as continuous variables) at each PEEP level is plotted and a multiadaptive linear regression is fitted.
Time Frame
Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Title
Respiratory system compliance (Crs) difference between standard and matched PEEP levels
Description
Respiratory system compliance measures the system's ability to stretch. It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20)
Time Frame
Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Title
Pulmonary compliance (Cp) difference
Description
Respiratory system compliance measures the system's ability to stretch (ml/cmH20). It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20). By using an esophageal probe measurement the two can be partitioned and analyzed separately.
Time Frame
Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Title
Chest wall compliance (CCw) difference
Description
Respiratory system compliance measures the system's ability to stretch (ml/cmH20). It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20). By using an esophageal probe measurement the two can be partitioned and analyzed separately.
Time Frame
Pneumoperitoneum insufflation before surgery (up to 30 minutes)
Title
Pulmonary Stress index difference
Description
Stress index is based on respiratory pressure curve analysis and assess whether the lungs are overdistended or collapsed
Time Frame
Pneumoperitoneum insufflation before surgery (up to 30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiology (ASA) risk scale I to III Age > 18 years Previously signed informed consent Undergoing laparoscopic surgery Exclusion Criteria: ASA ≥ IV Pregnancy Advanced liver, kidney or cardiopulmonary disease
Facility Information:
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26947624
Citation
Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4. Erratum In: Lancet Respir Med. 2016 Jun;4(6):e34.
Results Reference
background
PubMed Identifier
23863222
Citation
Cortes-Puentes GA, Gard KE, Adams AB, Faltesek KA, Anderson CP, Dries DJ, Marini JJ. Value and limitations of transpulmonary pressure calculations during intra-abdominal hypertension. Crit Care Med. 2013 Aug;41(8):1870-7. doi: 10.1097/CCM.0b013e31828a3bea.
Results Reference
background
PubMed Identifier
23196259
Citation
Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.
Results Reference
background
PubMed Identifier
28679201
Citation
D'Antini D, Rauseo M, Grasso S, Mirabella L, Camporota L, Cotoia A, Spadaro S, Fersini A, Petta R, Menga R, Sciusco A, Dambrosio M, Cinnella G. Physiological effects of the open lung approach during laparoscopic cholecystectomy: focus on driving pressure. Minerva Anestesiol. 2018 Feb;84(2):159-167. doi: 10.23736/S0375-9393.17.12042-0. Epub 2017 Jul 5.
Results Reference
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Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship During Laparoscopic Surgery

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