- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07928843
Effect of Head and Neck Positioning on Awake Fiberoptic Intubation in Obese Patients
Effect of Head and Neck Positioning on Awake Fiberoptic Intubation in Obese Patients: A Randomized Controlled Study
The aim of the study was the assessment and comparison of the time taken for vocal cord visualization with three different head positions: (conventional sniffing position, ramp position and supine position) in obese patients
연구 개요
상태
정황
상세 설명
Airway management in patients undergoing general anesthesia is a set of actions that result in the creation of a safe and secure airway for ventilation. Failure in airway management and hypoxia can lead to irreversible brain damages within only a few minutes .
The prevalence of obesity is rising worldwide, and this is a challenge for specialists in various fields of medicine. There is an inverse correlation between body weight and pharyngeal space. This association is significant because excess fat in morbid obesity can influence the pharyngeal spaces, and thus, significantly change laryngoscopic grade . Overall, airway management in obese patients can pose numerous challenges as these patients are at a higher risk for difficult airway than normal patients . In fact, patients with morbid obesity have excess fat in the mouth, neck, pharynx, thorax, breast, and abdomen, making access to the airway more problematic in various anesthesia situations such as intubation, tracheostomy, or mask ventilation as compared to normal subjects. In most studies, an increase in neck circumference was associated with difficult intubation, and a neck circumference over 60 cm was linked with a 35% likelihood of difficult intubation. Hence, the possibility of difficult intubation and problems with difficult airways in these patients should be considered, and a solution should be provided. In dealing with difficult airways, assistive devices such as fiberoptic bronchoscope and video-laryngoscope may be used in either awake or anesthetized patients .
Proper positioning before the induction of anesthesia is a key step in successful intubation . Numerous studies have emphasized the significance of head and neck positioning, which can have a significant impact on successful intubation and reduce tracheal injury and post-intubation complications .
The aim of the study was the assessment and comparison of the time taken for vocal cord visualization with three different head positions: (conventional sniffing position, ramp position and supine position) in obese patients
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cairo, 이집트
- Cairo University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age between 18 to 60 years old
- Body mass index more than 40 kg/m
- Potentially difficult intubation defined as mallampatti classification greater than two and neck circumference more than 40 cm
Exclusion Criteria:
- Age younger than 18 and more than 60 years old
- American Society of Anesthesiologists clinical status is more than four
- Sever mental disorder (psychotic or consider incapable of understanding the information)
- Mouth opening is less than 15 mm
- Poor dental status
- Contraindication to any drug used in the study
- patient refusal.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Group (S) Sniffing position
Group (S) Sniffing position : All patients will be explained the procedure on the day of surgery. Intravenous access will be gained a 16 through gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) will attach to the patients. The patient's airway will be anesthetized using aerosolized lignocaine 2%. The oral and pharyngeal reflexes will be blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles. |
Group (S) : patients will be explained the procedure on the day of surgery. Intravenous access will be gained a 16 through gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) will attach to the patients. The patient's airway will be anesthetized using aerosolized lignocaine 2%. The oral and pharyngeal reflexes will be blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles. The sniffing position will be made by placing 8 cm ring pillow under the patient head so that it will be tilted. The external auditory meatus will be aligned the sterna notch in the horizontal plane. The elevation of the operating and position of the anesthesiologist will be adjusted to ensure that the fiber-optic will be kept straight as it entered the patient's nasal cavity. The appropriate-sized endotracheal tube will be loaded over a 5mm external diameter flexible fiberoptic bronchoscope. Preoxygenation w |
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실험적: Group (R) Ramped position
Group (R) Ramped position: patients will be explained the process. Intravenous access will be gained and standard monitoring will be attached to the patients. The patient's airway will be anesthetized. After this, the patients will be helped to assume a ramped position. Three soft pillows will be positioned beneath the patient's head and upper body so that the external auditory meatus will be in a horizontal plane with a sternal notch. |
Group (R) Ramped position On the day of the operation, all Group R patients will be explained the process. Intravenous access will be gained and standard monitoring will be attached to the patients. The patient's airway will be anesthetized. After this, the patients will be helped to assume a ramped position. Three soft pillows will be positioned beneath the patient's head and upper body so that the external auditory meatus will be in a horizontal plane with a sternal notch. The elevation of the operating and position of the anesthesiologist will be adjusted to ensure that the fiber-optic was straight as it entered the patient's nasal cavity. An appropriately sized endotracheal tube will be loaded over a 5mm external diameter flexible fiberoptic bronchoscope. Preoxygenation will be performed with 100% oxygen with tidal volume ventilation for three to five minutes to achieve an end-expiratory oxygen concentration greater than 90%. |
|
실험적: Group (SU) Supine position
Group (SU) Supine position: All Group SU patients were explained the procedure on the day of surgery. Intravenous access was gained through a 16-gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) was attached to the patients. The patient's airway was anesthetized using aerosolized lignocaine 2%. The oral and pharyngeal reflexes were blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles. |
Group (SU) Supine position: patients were explained the procedure on the day of surgery. Intravenous access was gained through a 16-gauge cannula under local anesthesia. Standard monitoring (pulse oximeter, electrocardiography, non-invasive blood pressure) was attached to the patients. The patient's airway was anesthetized using aerosolized lignocaine 2%. The oral and pharyngeal reflexes were blunted by anesthetizing oral and pharyngeal mucosa with 10% lignocaine spray and gargles. The elevation of the operating and position of the anesthesiologist will be adjusted to ensure that the fiber-optic was kept straight as it entered the patient's nasal cavity. The appropriate-sized endotracheal tube will be loaded over a 5mm external diameter flexible fiberoptic bronchoscope. Preoxygenation will be performed with 100% oxygen with tidal volume ventilation for three to five minutes to achieve an end- expiratory oxygen concentration greater than 90%. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
comparison of the time taken for vocal cord visualization
기간: 1 hour
|
Assessment and comparison of the time taken for vocal cord visualization with three different head positions: (conventional sniffing position, ramp position and supine position) in obese patients. |
1 hour
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cough score for fiberoptic and for intubation
기간: 1 hour
|
Cough score for fiberoptic and for intubation (score range: 0 = none, 1 = slight, 2 = moderate, 3 = severe) |
1 hour
|
공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AP2609-501-179-213
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
It will be available if it needed
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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