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Effects of Recruitment Maneuver During Intraoperative Period

NCT ID: NCT04239547

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-08-01

Brief Summary

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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

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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.

Conditions

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Laparoscopic Hysterectomy

Keywords

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recruitment pulmonary complication oxygenisation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1, Alveolar Recruitment Maneuver+positive end expiratory pressure (PEEP) Group 2, PEEP
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The investigator, the participant and outcomes assessor will be masked to the intervention. Only the caregiver will be aware of the group and intervention received.

Study Groups

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Recruitment

Patients classified to receive recruitment maneuver + 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation.

Group Type EXPERIMENTAL

Alveolar Recruitment maneuver (ARM) +PEEP

Intervention Type PROCEDURE

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

Non-recruitment

Patients classified to receive only 5 mmHg positive end-expiratory pressure after anesthesia induction and intubation.

Group Type EXPERIMENTAL

PEEP

Intervention Type PROCEDURE

Following anesthesia induction and intubation, only 5 mmHg PEEP

Interventions

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Alveolar Recruitment maneuver (ARM) +PEEP

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

Intervention Type PROCEDURE

PEEP

Following anesthesia induction and intubation, only 5 mmHg PEEP

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Balikesir University

OTHER

Sponsor Role lead

Responsible Party

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Ozlem Sagir, MD

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Balikesir University

Balıkesir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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osagir-4

Identifier Type: -

Identifier Source: org_study_id