The goal of this observational study is to learn about hemodynamic and respiratory
      repercussions during general anesthesia in patients with achalasia or gastroparesis who
      underwent an endoscopic treatment such as a peroral endoscopic myotomy (POEM) or gastric
      (GPOEM).

      The main questions it aims to answer are:

        -  Are there predictable elements reliable to this study-population for the occurrence of
           adverse events/complications?

        -  Is there a correlation between the value (percutaneous puncture) of the intra-abdominal
           pressure and the variations of the patient's respiratory and hemodynamic parameters in
           the event of a pneumoperitoneum complication?

      Participants will be treated with the usual standard of care for this procedure and no
      additional or specific therapy will be planned for this study.

Respiratory and Hemodynamic Implications of Endoscopic Myotomy of the Esophagus and Stomach

Esophageal Achalasia

Gastroparesis

During the last ten years, the treatment of motor disorders of the esophagus and
      gastroparesis, by endoscopic approach, has become widespread. Because of its safety and
      effectiveness, this endoscopic technique has become the gold standard in esophageal and
      gastric motility disorders. This procedure consists of performing, under general anesthesia,
      a myotomy of the lower esophageal or pyloric sphincter, by performing a dissection under the
      mucous membrane beforehand. To properly expose the surgical site, the operator uses CO2,
      usually at a low flow rate, to reduce the risk of complications. However, subcutaneous
      emphysema (especially cervical), pneumoperitoneum, pneumothorax and pneumomediastinum occur
      in about 7.5-55% of cases, according to the literature. These adverse events frequently
      coincide with anesthetic difficulties. Indeed, the accumulation of CO2 outside the digestive
      lumen can disrupt mechanical ventilation (restrictive effect) by increasing intra-abdominal
      or intra-thoracic pressure. Consequently, the inspiratory pressure increases, the tidal
      volume decreases and the patient can desaturate. Therefore, stopping the endoscopic procedure
      is necessary and percutaneous CO2 exsufflation is indicated.

      The recent evolution of endoscopic treatment improves the future of these patients. However,
      the anesthetic management during this procedure remains poorly studied and depends mainly on
      the experience of the responsible physician.

      The aims of this prospective study are to be able to explore, on the basis of a detailed
      analysis of the patient profile (morphological data, medical/surgical history, drug
      treatment, etc.) and the various aspects of the endoscopic procedure (type of approach,
      procedure duration, dissection length, etc.), elements predictable for the occurrence of
      adverse events/complications (pneumoperitoneum, pneumothorax, haemorrhage, etc.); as well as
      being able to correlate the measurement (percutaneous puncture) of the intra-abdominal
      pressure to the variations of the respiratory and hemodynamic parameters of the patient in
      the event of a complication such as pneumoperitoneum. The results of this present project
      could make it possible to propose a more optimized anesthetic and gastroenterological
      management protocol for future patients, making it possible to minimize the risk of abdominal
      distension, as well as its respiratory and hemodynamic consequences.

      Potential participants will all be seen, informed and will be offered their participation in
      the study in preoperative anesthesia consultation, at the Lausanne University Hospital, at
      least 24 hours before the intervention. Once the eligibility criteria have been verified, the
      information and consent documents will be presented and detailed. The investigator will
      explain to each potential participant during the preoperative anesthesia consultation, the
      nature of the study, its purpose, the procedures involved, the expected duration, the
      potential risks and benefits, and any discomfort it may cause. Each participant will be
      informed that his/her participation in the study is voluntary and that he/she can withdraw
      from the study at any time and that the withdrawal of his/her consent will not affect his/her
      subsequent medical follow-up and treatment. The participant will be informed that his medical
      file may be examined by authorized persons other than his attending physician. All potential
      study participants will receive an information sheet and consent form describing the study
      and providing enough information for the participant to make an informed decision about
      participating in the study. The patient will have enough time (at least 24 hours) to decide
      whether or not to participate. If accepted, the consent form will be signed and dated by the
      investigator or his representative at the same time as the participant's signature on the day
      of the intervention. A copy of the signed informed consent will be given to the study
      participant. The consent form will be retained as part of the study records. The anesthetic
      evaluation during the consultation will always be done according to the criteria in force in
      our department. At each stage of the study, the patient will have the possibility of
      contacting an anesthesiologist, in case of questions, and withdrawing their consent to
      participate in the study without having to justify it.

      This study is exploratory in nature, with a primarily descriptive primary objective. The
      sample size is therefore not based on formal statistical methods. This is rather based on a
      feasibility estimate of the number of patients that can be included in 24 months by the
      anesthesiology department. According to the experience of this service, and taking into
      account the refusal of certain patients to participate in the study, 60 to 150 patients
      called for endoscopy treatment of the POEM or GPOEM type could be recruited in 24 months.
      Cases of pneumoperitoneum at the CHUV represent approximately 20% of patients having this
      type of treatment; we therefore estimate that the data from approximately thirty patients
      would serve for the exploratory analysis of the secondary objective of correlation between
      the modifications of the respiratory and hemodynamic parameters and the intra-abdominal
      pressure values.

      The primary objective is to describe the profile of patients in the presence or absence of
      adverse events. For each of the 2 groups, the following descriptions will be made:

        -  Continuous variables: minimum, 1st quartile, median, 2nd quartile, maximum (if deemed
           useful the results will be accompanied by a graphic representation: box-plot, dot-plot
           or violin plot)

        -  Qualitative variable: frequency and proportion per group

      The secondary objectives are:

        1. Identify predictors of adverse events/complications

           A logistic regression will be performed using a regularization method (lasso, elastic
           net) or by selecting a restricted set of variables (3 maximum). As this analysis is
           exploratory, and therefore, before fitting any type of regression model, the primary
           analysis described above will help to understand which models can be fitted, which
           covariate might or might not be included in the model.

        2. Correlate changes in respiratory and hemodynamic parameters to intra-abdominal pressure
           values

      The factors studied will be the respiratory parameters (ventilatory mode, peak pressure,
      plateau pressure, tidal volume, pressure support level, respiratory rate, PEEP, FiO2, SpO2
      and exhaled CO2) and hemodynamic values (mean arterial pressure, heart rate and use of
      vasopressors) throughout the endoscopic procedure. Correlations will be made on the subgroup
      of patients who have had pneumoperitoneum (estimate of about thirty patients). The Pearson
      and Spearman correlation coefficients as well as their 95% confidence intervals will be
      provided for the correlations between the continuous variables, the qualitative ones,
      respectively. For correlations between continuous and qualitative variables, the logistic
      regression method will be applied. The contingency tables will be presented in the case of
      two qualitative variables.

Respiratory and Hemodynamic Implications of Endoscopic Myotomy of the Esophagus and Stomach

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status