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Completed

NCT Number: NCT04239547

Effects of Recruitment Maneuver During Intraoperative Period

The aim of this study is to observe the effect of respiratory recruitment maneuver on intraoperative ventilatory parameters and postoperative pulmonary complications in patients over 18 years scheduled for laparoscopic hysterectomy.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Balikesir University

Balıkesir, Turkey (Türkiye)

About this study

In patients over 18 years who are scheduled for laparoscopic hysterectomy volunteering to participate in our study will receive anesthesia induction with one of our standard general anesthesia protocols. After intubation recruitment maneuver will be applied to the study group. General anesthesia and mechanical ventilation will be continued and completed according to our standard practice without any further intervention. Throughout the intraoperative period respiratory and haemodynamic parameters including compliance, airway resistance, mean arterial pressure, heart rate, pulse oxymetry, blood gas analysis, the applied inhalational anesthetic agent, minimum alveolar concentration, expiratory agent concentration and total agent consumption will be recorded. At the end of the operation anesthesia will be terminated and patients will be transferred to postanesthesia care unit (recovery unit after recovery and further discharged from to the ward when their Aldrete score is >8. The patients will be examined for respiratory complications on postoperative day 1, and will be followed up by telephone on day 5.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • American Society of Anesthesiology (ASA) I-II
  • > 18 y
  • laparoscopic hysterectomy patients

Exclusion criteria

  • Patient refusal to participate in the study
  • <18 y, BMI> 40
  • Patients receiving invasive MV support in the last 1 month
  • Patients who received chemotherapy or radiotherapy in the last 2 months
  • Patients with severe pulmonary disease (COPD, asthma, pulm infection, bronchiectasis) (those who have previously received Non-Invasive MV, oxygen therapy or steroid therapy for an acute attack)
  • Those with known severe pulmonary Hypertension
  • Intracranial tm
  • Hemodynamic instability
  • Shock.
  • Neuromuscular disease

Treatment and study plan

Alveolar Recruitment maneuver (ARM) +PEEP

Procedure

Following anesthesia induction and intubation, alveolar recruitment maneuver followed by 5 mmHg PEEP

PEEP

Procedure

Following anesthesia induction and intubation, only 5 mmHg PEEP

Primary outcomes

  1. measurement of change in airway compliance

    Time frame: T1:1minute(min)after intubationT2:5 min after Mechanical Ventilation(MV),T3:5 min after pneumoperitoneum,T4:3 min after Trendelenburg position(TP),T5:10 min after TP T6:20 min after TP T7:10 min after pneumoperitoneum deflation T8:1 min before extubation

    the patients airway compliance will be monitorised as milliliter / centimeter of water (mL/cmH2O) continuously by the anesthesia machine and will be recorded intermittently.

  2. measurement of change in Airway resistance

    Time frame: T1:1 minute after intubationT2:5 min after MV T3:5 minute after pneumoperitoneum T4:3 minute after Trendelenburg position (TP) T5:10 minutes after TP T6:20 minutes after TP T7:10 minutes after pneumoperitoneum deflation T8:1 minute before extubation

    the patients airway compliance will be monitorised as centimeter of water/ liter/ minute (cmH2O/L/min) continuously by the anesthesia machine and will be recorded intermittently.

  3. measurement of change in partial oxygen pressure (PaO2)

    Time frame: T1:1 minute after intubation T7: 10 minute after pneumoperitoneum deflation

    Arterial blood samples will be obtained and analysed. PaO2 will be recorded from these samples.

Secondary outcomes

  1. Evaluation of Postoperative respiratory distress, cough, phlegm

    Time frame: T9: 24 hours after surgery . T10: on postoperative day 5

    Pulmonary complications including respiratory distress, cough, phlegm will be evaluated by questionnaire and recorded.

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Official study title

Effects of Recruitment Maneuver on Perioperative Pulmonary Complications in Hysterectomies

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Nov 17, 2020

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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