Trial Outcomes & Findings for Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy (NCT NCT00942903)

Results Overview

the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

20 participants

Primary outcome timeframe

3 weeks

Results posted on

2010-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Provox XtraHME A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Provox XtraHME n=20 Participants A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age Continuous	66.4 years STANDARD_DEVIATION 9.07 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment Netherlands	20 patients n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

the patient preference is based on a structured questionnaire on several aspects regarding the use of the new Provox XtraHME in comparison with the Provox HME.

Outcome measures

Outcome measures
Measure	Provox XtraHME n=20 Participants A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
Patient Preference for Provox HME or Provox XtraHME Preference new Provox XtraHME	12 Patients
Patient Preference for Provox HME or Provox XtraHME Preference 'old' Provox HME	3 Patients
Patient Preference for Provox HME or Provox XtraHME No preference	5 Patients

SECONDARY outcome

Timeframe: 3 weeks

the number of patients presenting any hissing, whistling, or plopping noises before, during, or after stoma occlusion while using the new XtraHME

Outcome measures

Outcome measures
Measure	Provox XtraHME n=20 Participants A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
Noise at Stoma Occlusion No noise at stoma occlusion	20 patients
Noise at Stoma Occlusion Noise at stoma occlusion	0 patients

Adverse Events

Provox XtraHME

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. F.J.M. Hilgers

The Netherlands Cancer Institute

Phone: +31-20-5122550

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place