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NCT Number: NCT03435913

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

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.

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Key information

Conditions

Anesthesia, General/Methods End-Expiratory Pressure, Positive Laparoscopy Lung Diseases Lung Injury Pathologic Processes Pathological Conditions, Signs and Symptoms Positive-Pressure Respiration Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Fe

Valencia, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard PEEP ventilation

Other

During mechanical ventilation a fixed PEEP (5 mcH2O) is set at all IAP levels during pneumoperitoneum insufflation

Matched PEEP ventilation

Other

During mechanical ventilation PEEP is matched to IAP level

Primary outcomes

  1. Transpulmonary driving pressure (TpDp) difference between standard and matched PEEP ventilation

    Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)

    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 outcomes

  1. Transpulmonary driving pressure and intra-abdmominal pressure relationship (multivariate adaptive linear regression)

    Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)

    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.

  2. Transpulmonary driving pressure and respiratory driving pressure (RDp) relationship (multivariate adaptive linear regression).

    Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)

    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.

  3. Respiratory system compliance (Crs) difference between standard and matched PEEP levels

    Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)

    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)

  4. Pulmonary compliance (Cp) difference

    Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)

    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.

  5. Chest wall compliance (CCw) difference

    Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)

    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.

  6. Pulmonary Stress index difference

    Time frame: Pneumoperitoneum insufflation before surgery (up to 30 minutes)

    Stress index is based on respiratory pressure curve analysis and assess whether the lungs are overdistended or collapsed

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Registry information

Official study title

Assessment of Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship at Different Levels of Positive End-expiratory Pressure (PEEP) During Laparoscopic Surgery

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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