Clinical trial NCT04239547: Effects of Recruitment Maneuver During Intraoperative Period
Official title: Effects of Recruitment Maneuver on Perioperative Pulmonary Complications in Hysterectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Hysterectomy
Keywords: recruitment
pulmonary complication
oxygenisation
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1, Alveolar Recruitment Maneuver+positive end expiratory pressure (PEEP) Group 2, PEEP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: measurement of change in airway compliance
timeFrame: 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
measure: measurement of change in Airway resistance
timeFrame: 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
measure: measurement of change in partial oxygen pressure (PaO2)
timeFrame: T1:1 minute after intubation T7: 10 minute after pneumoperitoneum deflation
Secondary outcomes:
measure: Evaluation of Postoperative respiratory distress, cough, phlegm
timeFrame: T9: 24 hours after surgery . T10: on postoperative day 5
Other outcomes:
Locations:
city: Balikesir
country: Turkey
facility: Balikesir University
Study officials:
References: