Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627660
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia
Primary outcome Incidence of postoperative stridor and laryngospasm Secondary outcome incidence of reintubation postoperative hemodynamics duration of postoperative ICU and hospital stay
Primary outcome Incidence of postoperative stridor and laryngospasm Secondary outcome incidence of reintubation postoperative hemodynamics duration of postoperative ICU and hospital stay
Detailed Description:
Congenital Laryngomalacia is the main cause of stridor in newborns and infants affecting 45-75 of all infants with congenital stridor Short aryepiglottic folds redundant arytenoid omega-shaped epiglottis and inspiratory stridor are features of laryngomalacia Pediatric laryngospasm is a glottic closure due to reflex constriction of the laryngeal muscles that produce partial or complete obstruction of the larynx When complete and sustained laryngospasm is considered an anesthetic Emergency
The valsalva maneuver involves expiratory effort against a closed glottis in the sitting or supine position with the intraoral and intrathoracic pressures raised to 40 mmHg for 15-20 sec after which the pressure is suddenly released and the breathing restored to normal
We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia
After approval of IRB Mansoura University this study will be conducted on infants and children ASA I or II aging from 1 month age- 6 years undergoing supraglottoplasty in Mansoura university hospitals After obtaining a written informed consent from patients parents random number generator with closed envelope technique will randomize patients into two groups control group C group Valsalva group V group
Anesthesia will be induced by inhalational induction using sevoflurane at concentration 68 After that a proper sized cannula will be introduced with giving atropine 001mgkg and hydrocortisone 4mg kg Then patients will be seen by fiberoptic endoscopy by the surgeon to detect the stage of laryngomalacia and the supraglottic pathology After that proper sized ETT will be inserted using succinylcholine 1mgkg IV and fixed in place after confirmation of correct positioning with maintenance of anesthesia with isoflurane All patients will be given 05-1mic kg fentanyl and 15 mg kg paracetamol
A pilot study will be done including 5 patients in each study group The Incidence of postoperative stridor will be used as the primary variable with difference between studied groups was 40 50 in group C versus 10 in group V Gpower software version 3192 will be utilized to detect the required sample size for a study power of 90 and alpha error of 005 Cases involved in the pilot study will not be included in the total sample size of the study Then total sample size will be 26 in each group and by adding 10 to compensate for possible drop out then total sample size per group will be 29 cases in each group Perioperative data will be tabulated and analyzed using IBM SPSS software version 26
The valsalva maneuver involves expiratory effort against a closed glottis in the sitting or supine position with the intraoral and intrathoracic pressures raised to 40 mmHg for 15-20 sec after which the pressure is suddenly released and the breathing restored to normal
We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia
After approval of IRB Mansoura University this study will be conducted on infants and children ASA I or II aging from 1 month age- 6 years undergoing supraglottoplasty in Mansoura university hospitals After obtaining a written informed consent from patients parents random number generator with closed envelope technique will randomize patients into two groups control group C group Valsalva group V group
Anesthesia will be induced by inhalational induction using sevoflurane at concentration 68 After that a proper sized cannula will be introduced with giving atropine 001mgkg and hydrocortisone 4mg kg Then patients will be seen by fiberoptic endoscopy by the surgeon to detect the stage of laryngomalacia and the supraglottic pathology After that proper sized ETT will be inserted using succinylcholine 1mgkg IV and fixed in place after confirmation of correct positioning with maintenance of anesthesia with isoflurane All patients will be given 05-1mic kg fentanyl and 15 mg kg paracetamol
A pilot study will be done including 5 patients in each study group The Incidence of postoperative stridor will be used as the primary variable with difference between studied groups was 40 50 in group C versus 10 in group V Gpower software version 3192 will be utilized to detect the required sample size for a study power of 90 and alpha error of 005 Cases involved in the pilot study will not be included in the total sample size of the study Then total sample size will be 26 in each group and by adding 10 to compensate for possible drop out then total sample size per group will be 29 cases in each group Perioperative data will be tabulated and analyzed using IBM SPSS software version 26
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None