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Clinical Trials/NCT04239547
NCT04239547
Completed
Not Applicable

Effects of Recruitment Maneuver on Perioperative Pulmonary Complications in Hysterectomies

Balikesir University1 site in 1 country80 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laparoscopic Hysterectomy
Sponsor
Balikesir University
Enrollment
80
Locations
1
Primary Endpoint
measurement of change in Airway resistance
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
August 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Balikesir University
Responsible Party
Principal Investigator
Principal Investigator

Ozlem Sagir, MD

Associated professor

Balikesir University

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiology (ASA) I-II
  • 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
  • Neuromuscular disease

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Evaluation of Postoperative respiratory distress, cough, phlegm(T9: 24 hours after surgery . T10: on postoperative day 5)

Study Sites (1)

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